Trial Outcomes & Findings for A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (NCT NCT03104374)
NCT ID: NCT03104374
Last Updated: 2025-09-11
Results Overview
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
642 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2025-09-11
Participant Flow
This study was conducted at 123 sites in 16 countries (Belgium, Brazil, Canada, Chile, Czech Republic, France, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, United Kingdom, United States \[including Puerto Rico\]). Adults with active psoriatic arthritis (PsA) and a history of inadequate response or intolerance to at least one biologic disease modifying anti-rheumatic drug (bDMARD) were enrolled.
Participants were randomly assigned at a 1:1:2:2 ratio to one of four treatment groups below. Randomization was stratified by extent of psoriasis (≥ 3% body surface area \[BSA\] or \< 3% BSA), current use of at least 1 DMARD, and number of prior failed biologic DMARDs (1 vs \> 1), except for participants from Japan, for whom randomization was stratified by extent of psoriasis (≥ 3% BSA or \< 3% BSA) only.
Participant milestones
| Measure |
Placebo / Upadacitinib 15 mg
Participants randomized to receive placebo once daily up to week 24 followed by upadacitinib 15 mg once daily. All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures.
|
Placebo / Upadacitinib 30 mg
Participants randomized to receive placebo once daily up to week 24 followed by upadacitinib 30 mg once daily. All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures. Participants in this group were switched to upadacitinib 15mg QD during Period 2 after week 116, following a protocol amendment.
|
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily.
|
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily. Participants in this group were switched to upadacitinib 15mg QD during Period 2 after week 116, following a protocol amendment.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
106
|
106
|
211
|
219
|
|
Period 1
Received Study Drug
|
106
|
106
|
211
|
218
|
|
Period 1
Completed Week 24
|
81
|
92
|
192
|
195
|
|
Period 1
COMPLETED
|
69
|
77
|
167
|
166
|
|
Period 1
NOT COMPLETED
|
37
|
29
|
44
|
53
|
|
Period 2
STARTED
|
69
|
77
|
167
|
165
|
|
Period 2
Switched to 15mg QD Upa Dosing in Period 2
|
0
|
28
|
0
|
59
|
|
Period 2
COMPLETED
|
55
|
55
|
131
|
126
|
|
Period 2
NOT COMPLETED
|
14
|
22
|
36
|
39
|
Reasons for withdrawal
| Measure |
Placebo / Upadacitinib 15 mg
Participants randomized to receive placebo once daily up to week 24 followed by upadacitinib 15 mg once daily. All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures.
|
Placebo / Upadacitinib 30 mg
Participants randomized to receive placebo once daily up to week 24 followed by upadacitinib 30 mg once daily. All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures. Participants in this group were switched to upadacitinib 15mg QD during Period 2 after week 116, following a protocol amendment.
|
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily.
|
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily. Participants in this group were switched to upadacitinib 15mg QD during Period 2 after week 116, following a protocol amendment.
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
7
|
7
|
12
|
14
|
|
Period 1
Withdrawal by Subject
|
18
|
9
|
10
|
17
|
|
Period 1
Lost to Follow-up
|
4
|
4
|
6
|
8
|
|
Period 1
Lack of Efficacy
|
6
|
7
|
12
|
6
|
|
Period 1
Other
|
2
|
2
|
4
|
7
|
|
Period 1
One participant did not qualify per inclusion/exclusion criteria and discontinued prior to treatment
|
0
|
0
|
0
|
1
|
|
Period 2
Adverse Event
|
4
|
7
|
10
|
10
|
|
Period 2
Withdrawal by Subject
|
3
|
7
|
13
|
16
|
|
Period 2
Lost to Follow-up
|
2
|
2
|
3
|
5
|
|
Period 2
Lack of Efficacy
|
2
|
4
|
7
|
4
|
|
Period 2
COVID-19 Infection
|
0
|
0
|
1
|
0
|
|
Period 2
Other
|
3
|
2
|
2
|
4
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=212 Participants
Participants received placebo once daily for 24 weeks. This group includes all participants who went on to receive upadacitinib 15 mg or upadacitinib 30 mg after week 24.
|
Upadacitinib 15 mg
n=211 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=218 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
Total
n=641 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 11.53 • n=212 Participants
|
53.0 years
STANDARD_DEVIATION 12.02 • n=211 Participants
|
53.0 years
STANDARD_DEVIATION 11.94 • n=218 Participants
|
53.4 years
STANDARD_DEVIATION 11.83 • n=641 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=212 Participants
|
113 Participants
n=211 Participants
|
115 Participants
n=218 Participants
|
348 Participants
n=641 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=212 Participants
|
98 Participants
n=211 Participants
|
103 Participants
n=218 Participants
|
293 Participants
n=641 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=212 Participants
|
36 Participants
n=211 Participants
|
50 Participants
n=218 Participants
|
139 Participants
n=641 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=212 Participants
|
175 Participants
n=211 Participants
|
168 Participants
n=218 Participants
|
502 Participants
n=641 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=212 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=218 Participants
|
0 Participants
n=641 Participants
|
|
Race/Ethnicity, Customized
White
|
186 Participants
n=212 Participants
|
183 Participants
n=211 Participants
|
196 Participants
n=218 Participants
|
565 Participants
n=641 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=212 Participants
|
5 Participants
n=211 Participants
|
5 Participants
n=218 Participants
|
17 Participants
n=641 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=212 Participants
|
3 Participants
n=211 Participants
|
0 Participants
n=218 Participants
|
3 Participants
n=641 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=212 Participants
|
1 Participants
n=211 Participants
|
1 Participants
n=218 Participants
|
3 Participants
n=641 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=212 Participants
|
19 Participants
n=211 Participants
|
16 Participants
n=218 Participants
|
52 Participants
n=641 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=212 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=218 Participants
|
1 Participants
n=641 Participants
|
|
Extent of Psoriasis
< 3% BSA
|
81 Participants
n=212 Participants
|
81 Participants
n=211 Participants
|
87 Participants
n=218 Participants
|
249 Participants
n=641 Participants
|
|
Extent of Psoriasis
≥ 3% BSA
|
131 Participants
n=212 Participants
|
130 Participants
n=211 Participants
|
131 Participants
n=218 Participants
|
392 Participants
n=641 Participants
|
|
Number of Prior Failed Biologic DMARDs
0 bDMARDS
|
18 Participants
n=212 Participants
|
16 Participants
n=211 Participants
|
17 Participants
n=218 Participants
|
51 Participants
n=641 Participants
|
|
Number of Prior Failed Biologic DMARDs
1 bDMARD
|
135 Participants
n=212 Participants
|
126 Participants
n=211 Participants
|
130 Participants
n=218 Participants
|
391 Participants
n=641 Participants
|
|
Number of Prior Failed Biologic DMARDs
2 bDMARDS
|
35 Participants
n=212 Participants
|
35 Participants
n=211 Participants
|
46 Participants
n=218 Participants
|
116 Participants
n=641 Participants
|
|
Number of Prior Failed Biologic DMARDs
≥ 3 bDMARDS
|
24 Participants
n=212 Participants
|
34 Participants
n=211 Participants
|
25 Participants
n=218 Participants
|
83 Participants
n=641 Participants
|
|
Duration of Psoriatic Arthritis Symptoms
|
14.6 years
STANDARD_DEVIATION 11.70 • n=212 Participants
|
12.2 years
STANDARD_DEVIATION 8.81 • n=211 Participants
|
13.3 years
STANDARD_DEVIATION 10.84 • n=218 Participants
|
13.4 years
STANDARD_DEVIATION 10.54 • n=641 Participants
|
|
Duration of PsA Diagnosis
|
11.0 years
STANDARD_DEVIATION 10.33 • n=212 Participants
|
9.6 years
STANDARD_DEVIATION 8.36 • n=211 Participants
|
9.7 years
STANDARD_DEVIATION 8.71 • n=218 Participants
|
10.1 years
STANDARD_DEVIATION 9.18 • n=641 Participants
|
|
Tender Joint Count
|
25.3 joints
STANDARD_DEVIATION 17.62 • n=212 Participants
|
24.9 joints
STANDARD_DEVIATION 17.27 • n=211 Participants
|
24.2 joints
STANDARD_DEVIATION 15.87 • n=218 Participants
|
24.8 joints
STANDARD_DEVIATION 16.91 • n=641 Participants
|
|
Swollen Joint Count
|
12.0 joints
STANDARD_DEVIATION 8.85 • n=212 Participants
|
11.3 joints
STANDARD_DEVIATION 8.19 • n=211 Participants
|
12.9 joints
STANDARD_DEVIATION 9.41 • n=218 Participants
|
12.1 joints
STANDARD_DEVIATION 8.85 • n=641 Participants
|
|
Patient's Assessment of Pain
|
6.6 units on a scale
STANDARD_DEVIATION 2.12 • n=209 Participants • Participants with available data
|
6.4 units on a scale
STANDARD_DEVIATION 2.13 • n=208 Participants • Participants with available data
|
6.2 units on a scale
STANDARD_DEVIATION 2.21 • n=218 Participants • Participants with available data
|
6.4 units on a scale
STANDARD_DEVIATION 2.16 • n=635 Participants • Participants with available data
|
|
Patient's Global Assessment of Disease Activity
|
6.8 units on a scale
STANDARD_DEVIATION 2.04 • n=209 Participants • Participants with available data
|
6.8 units on a scale
STANDARD_DEVIATION 1.91 • n=208 Participants • Participants with available data
|
6.7 units on a scale
STANDARD_DEVIATION 2.15 • n=218 Participants • Participants with available data
|
6.8 units on a scale
STANDARD_DEVIATION 2.04 • n=635 Participants • Participants with available data
|
|
Physician's Global Assessment of Disease Activity
|
6.5 units on a scale
STANDARD_DEVIATION 1.76 • n=212 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.80 • n=211 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.73 • n=218 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.76 • n=641 Participants
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.23 units on a scale
STANDARD_DEVIATION 0.69 • n=209 Participants • Participants with available data
|
1.10 units on a scale
STANDARD_DEVIATION 0.61 • n=208 Participants • Participants with available data
|
1.19 units on a scale
STANDARD_DEVIATION 0.66 • n=218 Participants • Participants with available data
|
1.17 units on a scale
STANDARD_DEVIATION 0.66 • n=635 Participants • Participants with available data
|
|
High-sensitivity C-reactive Protein (hsCRP)
|
10.40 mg/L
STANDARD_DEVIATION 18.46 • n=212 Participants
|
11.16 mg/L
STANDARD_DEVIATION 18.55 • n=211 Participants
|
10.53 mg/L
STANDARD_DEVIATION 17.21 • n=218 Participants
|
10.69 mg/L
STANDARD_DEVIATION 18.05 • n=641 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=212 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=211 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=218 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
|
24.1 percentage of participants
Interval 18.3 to 29.8
|
56.9 percentage of participants
Interval 50.2 to 63.6
|
63.8 percentage of participants
Interval 57.4 to 70.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Placebo
n=180 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=199 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=204 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
|
-0.10 score on a scale
Interval -0.16 to -0.03
|
-0.30 score on a scale
Interval -0.37 to -0.24
|
-0.41 score on a scale
Interval -0.47 to -0.35
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full analysis set participants with a Baseline sIGA score ≥ 2; participants who prematurely discontinued from study drug prior to Week 16 or for whom sIGA data were missing at Week 16 were considered non-responders.
The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=171 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=164 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
|
9.2 percentage of participants
Interval 4.8 to 13.6
|
36.8 percentage of participants
Interval 29.6 to 44.1
|
40.2 percentage of participants
Interval 32.7 to 47.7
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; participants who prematurely discontinued from study drug prior to Week 16 or for whom PASI data were missing at Week 16 were considered non-responders.
PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score.
Outcome measures
| Measure |
Placebo
n=131 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=130 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=131 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
|
16.0 percentage of participants
Interval 9.7 to 22.3
|
52.3 percentage of participants
Interval 43.7 to 60.9
|
56.5 percentage of participants
Interval 48.0 to 65.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
Outcome measures
| Measure |
Placebo
n=185 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=201 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=206 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
|
1.62 score on a scale
Interval 0.58 to 2.67
|
5.15 score on a scale
Interval 4.14 to 6.15
|
7.06 score on a scale
Interval 6.07 to 8.06
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=184 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=201 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=206 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
|
1.3 score on a scale
Interval 0.1 to 2.5
|
5.0 score on a scale
Interval 3.8 to 6.1
|
6.1 score on a scale
Interval 4.9 to 7.2
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met rescue criteria at Week 16 were considered non-responders.
A participant was classified as achieving MDA if 5 of the following 7 criteria were met: * Tender joint count (out of 68 joints) ≤ 1 * Swollen joint count (out of 66 joints) ≤ 1 * PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3% * Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10) * Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10) * HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3) * Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
Outcome measures
| Measure |
Placebo
n=212 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=211 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=218 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
|
2.8 percentage of participants
Interval 0.6 to 5.1
|
25.1 percentage of participants
Interval 19.3 to 31.0
|
28.9 percentage of participants
Interval 22.9 to 34.9
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 16 was used.
The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
Outcome measures
| Measure |
Placebo
n=182 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=191 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=200 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
|
-1.5 score on a scale
Interval -4.7 to 1.8
|
-24.4 score on a scale
Interval -27.5 to -21.2
|
-29.7 score on a scale
Interval -32.8 to -26.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=212 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=211 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=218 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
|
4.7 percentage of participants
Interval 1.9 to 7.6
|
31.8 percentage of participants
Interval 25.5 to 38.0
|
37.6 percentage of participants
Interval 31.2 to 44.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=212 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=211 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=218 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
|
0.5 percentage of participants
Interval 0.0 to 1.4
|
8.5 percentage of participants
Interval 4.8 to 12.3
|
16.5 percentage of participants
Interval 11.6 to 21.4
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 2 or for whom ACR data were missing at Week 2 were considered non-responders.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=212 Participants
Participants received placebo once daily for 24 weeks.
|
Upadacitinib 15 mg
n=211 Participants
Participants received upadacitinib 15 mg once daily for 24 weeks.
|
Upadacitinib 30 mg
n=218 Participants
Participants received upadacitinib 30 mg once daily for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
|
10.8 percentage of participants
Interval 6.7 to 15.0
|
32.7 percentage of participants
Interval 26.4 to 39.0
|
33.5 percentage of participants
Interval 27.2 to 39.8
|
Adverse Events
Period 1: Upadacitinib 15 mg (ICF to Week 56)
Serious events: 22 serious events
Other events: 111 other events
Deaths: 0 deaths
Period 1: Upadacitinib 30 mg (ICF to Week 56)
Serious events: 25 serious events
Other events: 139 other events
Deaths: 0 deaths
Period 1: Pooled Placebo (ICF to Week 24)
Serious events: 5 serious events
Other events: 87 other events
Deaths: 1 deaths
Period 1: Placebo / Upadacitinib 15 mg (Week 24 to Week 56)
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Period 1: Placebo / Upadacitinib 30 mg (Week 24 to Week 56)
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Period 2: Upadacitinib 15 mg (Week 56 to EOS)
Serious events: 24 serious events
Other events: 111 other events
Deaths: 5 deaths
Period 2: Upadacitinib 30 mg (Week 56 to EOS)
Serious events: 19 serious events
Other events: 99 other events
Deaths: 0 deaths
Period 2: Placebo / Upadacitinib 15 mg (Week 56 to Week EOS)
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Period 2: Placebo / Upadacitinib 30 mg (Week 56 to EOS)
Serious events: 12 serious events
Other events: 49 other events
Deaths: 2 deaths
Period 2: Pooled Upadacitinib Groups Who Switched From 30 mg to 15 mg in Period 2
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Upadacitinib 15 mg (ICF to Week 56)
n=211 participants at risk
Participants randomized to receive Upadacitinib 15 mg once daily to Week 56.
|
Period 1: Upadacitinib 30 mg (ICF to Week 56)
n=219 participants at risk
Participants randomized to receive Upadacitinib 30 mg once daily to Week 56.
|
Period 1: Pooled Placebo (ICF to Week 24)
n=212 participants at risk
This group includes all participants in Period 1 who were randomized to receive Placebo once daily to Week 24.
|
Period 1: Placebo / Upadacitinib 15 mg (Week 24 to Week 56)
n=79 participants at risk
Participants were randomized to receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily to Week 56. AEs in this group were reported while participants received 15 mg upadacitinib from Week 24 to Week 56.
|
Period 1: Placebo / Upadacitinib 30 mg (Week 24 to Week 56)
n=90 participants at risk
Participants were randomized to receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily to Week 56. AEs in this group were reported while participants received 30 mg upadacitinib from Week 24 to Week 56.
|
Period 2: Upadacitinib 15 mg (Week 56 to EOS)
n=167 participants at risk
Participants randomized to receive upadacitinib 15 mg once daily in Period 2 from Week 56 to EOS.
|
Period 2: Upadacitinib 30 mg (Week 56 to EOS)
n=165 participants at risk
Participants randomized to receive upadacitinib 30 mg once daily in Period 2 from Week 56 to EOS. Participants in this group were switched to upadacitinib 15 mg once daily during Period 2 after week 116, following a protocol amendment.
|
Period 2: Placebo / Upadacitinib 15 mg (Week 56 to Week EOS)
n=69 participants at risk
Participants from the Period 1 Placebo / Upadacitinib 15 mg group received 15 mg upadacitinib once daily from Week 56 to EOS.
|
Period 2: Placebo / Upadacitinib 30 mg (Week 56 to EOS)
n=77 participants at risk
Participants from the Period 1 Placebo / Upadacitinib 30 mg group were to receive 30 mg upadacitinib once daily from Week 56 to EOS. Participants in this group were switched to upadacitinib 15 mg once daily during Period 2 after week 116, following a protocol amendment.
|
Period 2: Pooled Upadacitinib Groups Who Switched From 30 mg to 15 mg in Period 2
n=87 participants at risk
All participants in Period 2 who switched from 30 mg to 15 mg upadacitinib to EOS during Period 2. This group includes all participants who received any upadacitinib 30 mg in Period 2 and switched dose to upadacitinib 15 mg once daily during Period 2 (following a protocol amendment, after week 116). The AEs in this group were reported while participants received 15 mg upadacitinib once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
BLOOD LOSS ANAEMIA
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/167 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Endocrine disorders
GOITRE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
SMALL INTESTINE ULCER
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
General disorders
CHEST PAIN
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
General disorders
DEATH
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
General disorders
PYREXIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
ABSCESS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
BRONCHIOLITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
BURSITIS INFECTIVE STAPHYLOCOCCAL
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
COVID-19
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.8%
3/167 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/165 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/167 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
EXTRADURAL ABSCESS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
HIV INFECTION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
LIVER ABSCESS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION BACTERIAL
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
OSTEOMYELITIS ACUTE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
PNEUMONIA
|
1.4%
3/211 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
3/219 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/165 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.3%
2/87 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
SEPSIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
FALL
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL BILE LEAK
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMOTHORAX
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.95%
2/211 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/167 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
RAPIDLY PROGRESSIVE OSTEOARTHRITIS
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL CANCER METASTATIC
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL CARCINOMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRADUCTAL PAPILLARY BREAST NEOPLASM
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA STAGE III
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA OF THE SKIN
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL SQUAMOUS CELL CARCINOMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN THECA CELL TUMOUR
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARATHYROID TUMOUR BENIGN
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
CAROTID ARTERY INSUFFICIENCY
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
DIZZINESS
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
FACIAL PARALYSIS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
SPEECH DISORDER
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Nervous system disorders
TRANSIENT GLOBAL AMNESIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.61%
1/165 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Psychiatric disorders
DISORIENTATION
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.95%
2/211 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/167 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.60%
1/167 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/165 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
Other adverse events
| Measure |
Period 1: Upadacitinib 15 mg (ICF to Week 56)
n=211 participants at risk
Participants randomized to receive Upadacitinib 15 mg once daily to Week 56.
|
Period 1: Upadacitinib 30 mg (ICF to Week 56)
n=219 participants at risk
Participants randomized to receive Upadacitinib 30 mg once daily to Week 56.
|
Period 1: Pooled Placebo (ICF to Week 24)
n=212 participants at risk
This group includes all participants in Period 1 who were randomized to receive Placebo once daily to Week 24.
|
Period 1: Placebo / Upadacitinib 15 mg (Week 24 to Week 56)
n=79 participants at risk
Participants were randomized to receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily to Week 56. AEs in this group were reported while participants received 15 mg upadacitinib from Week 24 to Week 56.
|
Period 1: Placebo / Upadacitinib 30 mg (Week 24 to Week 56)
n=90 participants at risk
Participants were randomized to receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily to Week 56. AEs in this group were reported while participants received 30 mg upadacitinib from Week 24 to Week 56.
|
Period 2: Upadacitinib 15 mg (Week 56 to EOS)
n=167 participants at risk
Participants randomized to receive upadacitinib 15 mg once daily in Period 2 from Week 56 to EOS.
|
Period 2: Upadacitinib 30 mg (Week 56 to EOS)
n=165 participants at risk
Participants randomized to receive upadacitinib 30 mg once daily in Period 2 from Week 56 to EOS. Participants in this group were switched to upadacitinib 15 mg once daily during Period 2 after week 116, following a protocol amendment.
|
Period 2: Placebo / Upadacitinib 15 mg (Week 56 to Week EOS)
n=69 participants at risk
Participants from the Period 1 Placebo / Upadacitinib 15 mg group received 15 mg upadacitinib once daily from Week 56 to EOS.
|
Period 2: Placebo / Upadacitinib 30 mg (Week 56 to EOS)
n=77 participants at risk
Participants from the Period 1 Placebo / Upadacitinib 30 mg group were to receive 30 mg upadacitinib once daily from Week 56 to EOS. Participants in this group were switched to upadacitinib 15 mg once daily during Period 2 after week 116, following a protocol amendment.
|
Period 2: Pooled Upadacitinib Groups Who Switched From 30 mg to 15 mg in Period 2
n=87 participants at risk
All participants in Period 2 who switched from 30 mg to 15 mg upadacitinib to EOS during Period 2. This group includes all participants who received any upadacitinib 30 mg in Period 2 and switched dose to upadacitinib 15 mg once daily during Period 2 (following a protocol amendment, after week 116). The AEs in this group were reported while participants received 15 mg upadacitinib once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
3.8%
8/211 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.8%
15/219 • Number of events 18 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.7%
12/212 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.8%
3/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.3%
3/90 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.0%
5/167 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.8%
3/165 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.6%
2/77 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.6%
4/87 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Gastrointestinal disorders
NAUSEA
|
3.8%
8/211 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.5%
12/219 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.3%
7/212 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.4%
4/167 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.1%
10/165 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/69 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
3/219 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.0%
5/167 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.8%
3/165 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.5%
5/77 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
BRONCHITIS
|
8.1%
17/211 • Number of events 20 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.8%
15/219 • Number of events 16 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.4%
5/212 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.3%
5/79 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.4%
4/90 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
9.0%
15/167 • Number of events 17 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.8%
8/165 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
8.7%
6/69 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.2%
4/77 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.3%
2/87 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
COVID-19
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/219 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
12.6%
21/167 • Number of events 21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.3%
12/165 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
10.1%
7/69 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
9.1%
7/77 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
16.1%
14/87 • Number of events 17 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
HERPES ZOSTER
|
3.8%
8/211 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.9%
13/219 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.94%
2/212 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.5%
2/79 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.6%
5/90 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.0%
10/167 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.9%
13/165 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.3%
3/69 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.5%
5/77 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
INFLUENZA
|
6.6%
14/211 • Number of events 16 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.9%
13/219 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
3/212 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.5%
2/79 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.2%
2/90 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.8%
3/167 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.6%
6/165 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.9%
2/69 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.3%
1/77 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.4%
24/211 • Number of events 29 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
13.2%
29/219 • Number of events 34 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
8.0%
17/212 • Number of events 18 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.3%
5/79 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.7%
6/90 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
8.4%
14/167 • Number of events 17 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.3%
12/165 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
10.1%
7/69 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.8%
6/77 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.7%
5/87 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
PNEUMONIA
|
0.47%
1/211 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
3/219 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.94%
2/212 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.5%
2/79 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/167 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.4%
4/165 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.2%
4/77 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
SINUSITIS
|
3.8%
8/211 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.1%
9/219 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.2%
9/212 • Number of events 11 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.8%
3/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.2%
7/167 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.2%
7/165 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.9%
2/69 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.8%
6/77 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
TOOTH INFECTION
|
1.4%
3/211 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
3/219 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/167 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.4%
4/165 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.8%
4/69 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/77 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.4%
22/211 • Number of events 27 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
13.2%
29/219 • Number of events 34 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.7%
10/212 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.6%
6/79 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
9.0%
15/167 • Number of events 15 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.5%
9/165 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.2%
5/69 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.8%
6/77 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.4%
3/87 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.0%
19/211 • Number of events 24 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.3%
16/219 • Number of events 18 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.7%
12/212 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.1%
4/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.4%
4/90 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
10.2%
17/167 • Number of events 24 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
8.5%
14/165 • Number of events 22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
11.6%
8/69 • Number of events 11 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
11.7%
9/77 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.4%
3/87 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.4%
5/211 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.0%
11/219 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.47%
1/212 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.4%
4/90 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.6%
6/167 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.6%
6/165 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.3%
3/69 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.6%
2/77 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
4.3%
9/211 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
10.0%
22/219 • Number of events 29 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.9%
4/212 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.5%
2/79 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.4%
4/90 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.8%
13/167 • Number of events 15 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.5%
9/165 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.2%
5/69 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.8%
6/77 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.3%
2/87 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/211 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.46%
1/219 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/212 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/79 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.2%
2/167 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.4%
4/165 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.4%
1/69 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.2%
4/77 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
0.00%
0/87 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
6.2%
13/211 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.2%
7/219 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.2%
11/212 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
2.5%
2/79 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.3%
3/90 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.2%
12/167 • Number of events 15 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
9.7%
16/165 • Number of events 18 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
13.0%
9/69 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
10.4%
8/77 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
9.2%
8/87 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
|
Vascular disorders
HYPERTENSION
|
3.8%
8/211 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.6%
10/219 • Number of events 10 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
4.7%
10/212 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
5.1%
4/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
3.3%
3/90 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
11.4%
19/167 • Number of events 20 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
6.7%
11/165 • Number of events 11 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
7.2%
5/69 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
9.1%
7/77 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
1.1%
1/87 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER