Trial Outcomes & Findings for A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (NCT NCT02675426)
NCT ID: NCT02675426
Last Updated: 2023-04-11
Results Overview
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. 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
661 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-04-11
Participant Flow
Participants were randomized at 149 centers in 35 countries in North America, eastern and western Europe, Asia, South America, Australia, New Zealand, and South Africa. The study included a 12-week placebo-controlled, double-blind period (Period 1), and a 5-year (248-week) double-blind extension (Period 2).
Participants were randomly assigned in a 1:1:2:2 ratio to one of the four treatment groups below. Randomization was stratified by prior exposure to biologic disease-modifying anti-rheumatic drug (bDMARD) and geographical region.
Participant milestones
| Measure |
Placebo / Upadacitinib 15 mg
Participants received placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for 248 weeks in Period 2.
|
Placebo / Upadacitinib 30 mg
Participants received placebo once daily for 12 weeks in Period 1 followed by upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time they were switched to receive upadacitinib 15 mg once daily.
|
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1 and continued to receive upadacitinib 15 mg once daily for an additional 248 weeks in Period 2.
|
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1. In Period 2 participants continued to receive upadacitinib 30 mg for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants were switched to receive upadacitinib 15 mg once daily.
|
|---|---|---|---|---|
|
Period 1: Week 1 to Week 12
STARTED
|
110
|
111
|
221
|
219
|
|
Period 1: Week 1 to Week 12
Received Study Drug
|
110
|
111
|
221
|
219
|
|
Period 1: Week 1 to Week 12
COMPLETED
|
104
|
104
|
213
|
201
|
|
Period 1: Week 1 to Week 12
NOT COMPLETED
|
6
|
7
|
8
|
18
|
|
Period 2: Week 12 to Week 260
STARTED
|
103
|
103
|
212
|
200
|
|
Period 2: Week 12 to Week 260
Received Study Drug
|
103
|
102
|
207
|
199
|
|
Period 2: Week 12 to Week 260
Switched to Upadacitinib 15 mg After Protocol Amendment 6
|
0
|
53
|
0
|
126
|
|
Period 2: Week 12 to Week 260
COMPLETED
|
61
|
49
|
130
|
120
|
|
Period 2: Week 12 to Week 260
NOT COMPLETED
|
42
|
54
|
82
|
80
|
Reasons for withdrawal
| Measure |
Placebo / Upadacitinib 15 mg
Participants received placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for 248 weeks in Period 2.
|
Placebo / Upadacitinib 30 mg
Participants received placebo once daily for 12 weeks in Period 1 followed by upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time they were switched to receive upadacitinib 15 mg once daily.
|
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1 and continued to receive upadacitinib 15 mg once daily for an additional 248 weeks in Period 2.
|
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1. In Period 2 participants continued to receive upadacitinib 30 mg for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants were switched to receive upadacitinib 15 mg once daily.
|
|---|---|---|---|---|
|
Period 1: Week 1 to Week 12
Adverse Event
|
3
|
3
|
3
|
9
|
|
Period 1: Week 1 to Week 12
Withdrawal by Subject
|
1
|
2
|
5
|
5
|
|
Period 1: Week 1 to Week 12
Lost to Follow-up
|
0
|
1
|
0
|
2
|
|
Period 1: Week 1 to Week 12
Other
|
2
|
1
|
0
|
2
|
|
Period 2: Week 12 to Week 260
Adverse Event
|
13
|
16
|
17
|
30
|
|
Period 2: Week 12 to Week 260
Withdrawal by Subject
|
14
|
21
|
31
|
30
|
|
Period 2: Week 12 to Week 260
Lost to Follow-up
|
5
|
5
|
10
|
4
|
|
Period 2: Week 12 to Week 260
Coronavirus Disease - 2019 (COVID-19) Infection
|
1
|
0
|
0
|
1
|
|
Period 2: Week 12 to Week 260
COVID-19 Logistic Restrictions
|
1
|
0
|
1
|
0
|
|
Period 2: Week 12 to Week 260
Other
|
8
|
12
|
23
|
15
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 12.22 • n=221 Participants
|
55.3 years
STANDARD_DEVIATION 11.47 • n=221 Participants
|
55.8 years
STANDARD_DEVIATION 11.29 • n=219 Participants
|
55.7 years
STANDARD_DEVIATION 11.65 • n=661 Participants
|
|
Age, Customized
< 40 years
|
21 Participants
n=221 Participants
|
23 Participants
n=221 Participants
|
22 Participants
n=219 Participants
|
66 Participants
n=661 Participants
|
|
Age, Customized
40 to 64 years
|
145 Participants
n=221 Participants
|
153 Participants
n=221 Participants
|
145 Participants
n=219 Participants
|
443 Participants
n=661 Participants
|
|
Age, Customized
≥ 65 years
|
55 Participants
n=221 Participants
|
45 Participants
n=221 Participants
|
52 Participants
n=219 Participants
|
152 Participants
n=661 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=221 Participants
|
182 Participants
n=221 Participants
|
172 Participants
n=219 Participants
|
520 Participants
n=661 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=221 Participants
|
39 Participants
n=221 Participants
|
47 Participants
n=219 Participants
|
141 Participants
n=661 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=221 Participants
|
23 Participants
n=221 Participants
|
30 Participants
n=219 Participants
|
80 Participants
n=661 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=221 Participants
|
198 Participants
n=221 Participants
|
189 Participants
n=219 Participants
|
581 Participants
n=661 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=221 Participants
|
0 Participants
n=221 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=661 Participants
|
|
Race/Ethnicity, Customized
White
|
187 Participants
n=221 Participants
|
188 Participants
n=221 Participants
|
186 Participants
n=219 Participants
|
561 Participants
n=661 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=221 Participants
|
13 Participants
n=221 Participants
|
8 Participants
n=219 Participants
|
31 Participants
n=661 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaskan Native
|
1 Participants
n=221 Participants
|
0 Participants
n=221 Participants
|
1 Participants
n=219 Participants
|
2 Participants
n=661 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=221 Participants
|
19 Participants
n=221 Participants
|
21 Participants
n=219 Participants
|
59 Participants
n=661 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
4 Participants
n=221 Participants
|
1 Participants
n=221 Participants
|
3 Participants
n=219 Participants
|
8 Participants
n=661 Participants
|
|
Geographical Region
North America
|
90 Participants
n=221 Participants
|
88 Participants
n=221 Participants
|
89 Participants
n=219 Participants
|
267 Participants
n=661 Participants
|
|
Geographical Region
South/Central America
|
8 Participants
n=221 Participants
|
10 Participants
n=221 Participants
|
11 Participants
n=219 Participants
|
29 Participants
n=661 Participants
|
|
Geographical Region
Western Europe
|
24 Participants
n=221 Participants
|
22 Participants
n=221 Participants
|
23 Participants
n=219 Participants
|
69 Participants
n=661 Participants
|
|
Geographical Region
Eastern Europe
|
74 Participants
n=221 Participants
|
76 Participants
n=221 Participants
|
73 Participants
n=219 Participants
|
223 Participants
n=661 Participants
|
|
Geographical Region
Asia
|
16 Participants
n=221 Participants
|
17 Participants
n=221 Participants
|
15 Participants
n=219 Participants
|
48 Participants
n=661 Participants
|
|
Geographical Region
Other
|
9 Participants
n=221 Participants
|
8 Participants
n=221 Participants
|
8 Participants
n=219 Participants
|
25 Participants
n=661 Participants
|
|
Prior Biological DMARD Use
Yes
|
29 Participants
n=221 Participants
|
27 Participants
n=221 Participants
|
28 Participants
n=219 Participants
|
84 Participants
n=661 Participants
|
|
Prior Biological DMARD Use
No
|
192 Participants
n=221 Participants
|
194 Participants
n=221 Participants
|
191 Participants
n=219 Participants
|
577 Participants
n=661 Participants
|
|
Duration of Rheumatoid Arthritis (RA) Diagnosis
|
7.2 years
STANDARD_DEVIATION 7.45 • n=221 Participants
|
7.3 years
STANDARD_DEVIATION 7.89 • n=221 Participants
|
7.3 years
STANDARD_DEVIATION 7.86 • n=219 Participants
|
7.3 years
STANDARD_DEVIATION 7.72 • n=661 Participants
|
|
Conventional Synthetic DMARD (csDMARD) Use at Baseline
Methotrexate alone
|
141 Participants
n=221 Participants
|
122 Participants
n=221 Participants
|
136 Participants
n=219 Participants
|
399 Participants
n=661 Participants
|
|
Conventional Synthetic DMARD (csDMARD) Use at Baseline
Methotrexate and other csDMARD
|
49 Participants
n=221 Participants
|
47 Participants
n=221 Participants
|
39 Participants
n=219 Participants
|
135 Participants
n=661 Participants
|
|
Conventional Synthetic DMARD (csDMARD) Use at Baseline
csDMARD other than methotrexate
|
30 Participants
n=221 Participants
|
51 Participants
n=221 Participants
|
44 Participants
n=219 Participants
|
125 Participants
n=661 Participants
|
|
Conventional Synthetic DMARD (csDMARD) Use at Baseline
Missing
|
1 Participants
n=221 Participants
|
1 Participants
n=221 Participants
|
0 Participants
n=219 Participants
|
2 Participants
n=661 Participants
|
|
Tender Joint Count
|
24.7 tender joints
STANDARD_DEVIATION 14.96 • n=221 Participants
|
25.2 tender joints
STANDARD_DEVIATION 13.80 • n=221 Participants
|
26.2 tender joints
STANDARD_DEVIATION 14.26 • n=219 Participants
|
25.4 tender joints
STANDARD_DEVIATION 14.34 • n=661 Participants
|
|
Swollen Joint Count
|
15.4 swollen joints
STANDARD_DEVIATION 9.24 • n=221 Participants
|
16.0 swollen joints
STANDARD_DEVIATION 10.04 • n=221 Participants
|
16.2 swollen joints
STANDARD_DEVIATION 10.55 • n=219 Participants
|
15.8 swollen joints
STANDARD_DEVIATION 9.95 • n=661 Participants
|
|
Patient's Assessment of Pain
|
61.5 units on a scale
STANDARD_DEVIATION 20.80 • n=221 Participants • Participants with available data
|
64.1 units on a scale
STANDARD_DEVIATION 19.45 • n=217 Participants • Participants with available data
|
64.0 units on a scale
STANDARD_DEVIATION 19.77 • n=219 Participants • Participants with available data
|
63.2 units on a scale
STANDARD_DEVIATION 20.02 • n=657 Participants • Participants with available data
|
|
Patient's Global Assessment of Disease Activity
|
60.3 units on a scale
STANDARD_DEVIATION 20.50 • n=221 Participants • Participants with available data
|
63.1 units on a scale
STANDARD_DEVIATION 21.86 • n=217 Participants • Participants with available data
|
62.8 units on a scale
STANDARD_DEVIATION 20.32 • n=219 Participants • Participants with available data
|
62.1 units on a scale
STANDARD_DEVIATION 20.91 • n=657 Participants • Participants with available data
|
|
Physician's Global Assessment of Disease Activity
|
64.4 units on a scale
STANDARD_DEVIATION 17.67 • n=211 Participants • Participants with available data
|
64.3 units on a scale
STANDARD_DEVIATION 16.22 • n=209 Participants • Participants with available data
|
63.0 units on a scale
STANDARD_DEVIATION 17.99 • n=213 Participants • Participants with available data
|
63.9 units on a scale
STANDARD_DEVIATION 17.30 • n=633 Participants • Participants with available data
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.4 units on a scale
STANDARD_DEVIATION 0.63 • n=221 Participants • Participants with available data
|
1.5 units on a scale
STANDARD_DEVIATION 0.61 • n=216 Participants • Participants with available data
|
1.5 units on a scale
STANDARD_DEVIATION 0.61 • n=219 Participants • Participants with available data
|
1.5 units on a scale
STANDARD_DEVIATION 0.62 • n=656 Participants • Participants with available data
|
|
High-sensitivity C-reactive Protein (hsCRP)
|
12.6 mg/L
STANDARD_DEVIATION 13.96 • n=221 Participants
|
16.6 mg/L
STANDARD_DEVIATION 19.17 • n=221 Participants
|
14.8 mg/L
STANDARD_DEVIATION 16.86 • n=219 Participants
|
14.7 mg/L
STANDARD_DEVIATION 16.86 • n=661 Participants
|
|
Disease Activity Score Based on CRP (DAS28 [CRP])
|
5.6 units on a scale
STANDARD_DEVIATION 0.84 • n=221 Participants • Participants with available data
|
5.7 units on a scale
STANDARD_DEVIATION 0.97 • n=217 Participants • Participants with available data
|
5.7 units on a scale
STANDARD_DEVIATION 0.90 • n=219 Participants • Participants with available data
|
5.6 units on a scale
STANDARD_DEVIATION 0.91 • n=657 Participants • Participants with available data
|
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.
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. 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=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
|
35.7 percentage of participants
Interval 29.4 to 42.1
|
63.8 percentage of participants
Interval 57.5 to 70.1
|
66.2 percentage of participants
Interval 59.9 to 72.5
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 12. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity.
Outcome measures
| Measure |
Placebo
n=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
|
17.2 percentage of participants
Interval 12.2 to 22.2
|
48.4 percentage of participants
Interval 41.8 to 55.0
|
47.9 percentage of participants
Interval 41.3 to 54.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo
n=220 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=217 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
|
-1.02 units on a scale
Interval -1.22 to -0.82
|
-2.20 units on a scale
Interval -2.4 to -2.0
|
-2.34 units on a scale
Interval -2.54 to -2.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data at baseline; multiple imputation was used for missing data.
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=220 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=216 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
|
-0.25 units on a scale
Interval -0.34 to -0.17
|
-0.59 units on a scale
Interval -0.67 to -0.51
|
-0.54 units on a scale
Interval -0.62 to -0.46
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases 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 summary 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=207 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=209 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=197 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12
|
3.03 units on a scale
Interval 1.88 to 4.18
|
7.58 units on a scale
Interval 6.43 to 8.74
|
8.01 units on a scale
Interval 6.84 to 9.18
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 (CRP) data were missing at Week 12 were considered non-responders.
Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
Placebo
n=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
|
10.0 percentage of participants
Interval 6.0 to 13.9
|
30.8 percentage of participants
Interval 24.7 to 36.9
|
28.3 percentage of participants
Interval 22.3 to 34.3
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom CDAI data were missing at Week 12 were considered non-responders.
Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Placebo
n=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
|
19.0 percentage of participants
Interval 13.8 to 24.2
|
40.3 percentage of participants
Interval 33.8 to 46.7
|
42.0 percentage of participants
Interval 35.5 to 48.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days.
Outcome measures
| Measure |
Placebo
n=202 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=207 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=197 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Change From Baseline in Duration of Morning Stiffness at Week 12
|
-34.27 minutes
Interval -54.63 to -13.91
|
-85.28 minutes
Interval -105.61 to -64.95
|
-85.13 minutes
Interval -105.65 to -64.62
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=207 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=207 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=197 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
|
2.96 units on a scale
Interval 1.62 to 4.3
|
7.91 units on a scale
Interval 6.56 to 9.27
|
7.74 units on a scale
Interval 6.38 to 9.11
|
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=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
|
14.9 percentage of participants
Interval 10.2 to 19.6
|
38.0 percentage of participants
Interval 31.6 to 44.4
|
43.4 percentage of participants
Interval 36.8 to 49.9
|
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=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
|
5.9 percentage of participants
Interval 2.8 to 9.0
|
20.8 percentage of participants
Interval 15.5 to 26.2
|
26.5 percentage of participants
Interval 20.6 to 32.3
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 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=221 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=221 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=219 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
|
8.6 percentage of participants
Interval 4.9 to 12.3
|
22.2 percentage of participants
Interval 16.7 to 27.6
|
28.3 percentage of participants
Interval 22.3 to 34.3
|
Adverse Events
Period 1: Placebo
Serious events: 5 serious events
Other events: 68 other events
Deaths: 1 deaths
Period 1: Upadacitinib 15 mg
Serious events: 10 serious events
Other events: 83 other events
Deaths: 0 deaths
Period 1: Upadacitinib 30 mg
Serious events: 7 serious events
Other events: 74 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 15 mg
Serious events: 91 serious events
Other events: 241 other events
Deaths: 4 deaths
Period1+2: Upadacitinib 30 mg
Serious events: 102 serious events
Other events: 233 other events
Deaths: 7 deaths
Period 2: Upadacitinib 15 mg After Switch
Serious events: 19 serious events
Other events: 51 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Period 1: Placebo
n=221 participants at risk
Participants received placebo once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 15 mg
n=221 participants at risk
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 30 mg
n=219 participants at risk
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Period 1+2: Upadacitinib 15 mg
n=324 participants at risk
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg for 260 weeks and participants originally randomized to placebo followed by upadacitinib 15 mg received upadacitinib 15 mg from Week 12 to Week 260.
|
Period1+2: Upadacitinib 30 mg
n=321 participants at risk
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg up to Week 260 or implementation of Protocol Amendment 6 (December 2019) and participants originally randomized to placebo followed by upadacitinib 30 mg received upadacitinib 30 mg from Week 12 up to Week 260 or up to implementation of Protocol Amendment 6.
|
Period 2: Upadacitinib 15 mg After Switch
n=179 participants at risk
Participants who were receiving upadacitinib 30 mg in Period 2 were switched to upadacitinib 15 mg once daily after implementation of Protocol Amendment 6 (December 2019) up to Week 260.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.6%
5/321 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.2%
4/324 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Endocrine disorders
Goitre
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Eye disorders
Corneal decompensation
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Eye disorders
Retinal tear
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Dysbiosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Chest pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Non-cardiac chest pain
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Oedema peripheral
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Prosthetic cardiac valve stenosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Pyrexia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.93%
3/321 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.2%
4/321 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
COVID-19
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.9%
6/324 • Number of events 6 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.2%
4/179 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Extrapulmonary tuberculosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Groin abscess
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Herpes zoster cutaneous disseminated
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Influenza
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Lung abscess
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Pneumonia
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.9%
6/324 • Number of events 6 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.4%
11/321 • Number of events 13 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Sepsis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.2%
4/321 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Septic shock
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Varicella
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.93%
3/321 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
Yersinia infection
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.93%
3/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Joint dislocation postoperative
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
Liver function test increased
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
Troponin increased
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
Weight decreased
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
Weight increased
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.93%
3/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.9%
6/324 • Number of events 11 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.5%
8/321 • Number of events 8 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.1%
2/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage I
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma recurrent
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Headache
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Syncope
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Product Issues
Device breakage
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Product Issues
Device material issue
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Psychiatric disorders
Behaviour disorder
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Psychiatric disorders
Depression
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.93%
3/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/324 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.93%
3/324 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/324 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Surgical and medical procedures
Therapy change
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/321 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Vascular disorders
Hypotension
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/324 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.31%
1/321 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
Other adverse events
| Measure |
Period 1: Placebo
n=221 participants at risk
Participants received placebo once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 15 mg
n=221 participants at risk
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 30 mg
n=219 participants at risk
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Period 1+2: Upadacitinib 15 mg
n=324 participants at risk
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg for 260 weeks and participants originally randomized to placebo followed by upadacitinib 15 mg received upadacitinib 15 mg from Week 12 to Week 260.
|
Period1+2: Upadacitinib 30 mg
n=321 participants at risk
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg up to Week 260 or implementation of Protocol Amendment 6 (December 2019) and participants originally randomized to placebo followed by upadacitinib 30 mg received upadacitinib 30 mg from Week 12 up to Week 260 or up to implementation of Protocol Amendment 6.
|
Period 2: Upadacitinib 15 mg After Switch
n=179 participants at risk
Participants who were receiving upadacitinib 30 mg in Period 2 were switched to upadacitinib 15 mg once daily after implementation of Protocol Amendment 6 (December 2019) up to Week 260.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.2%
20/324 • Number of events 24 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.1%
10/321 • Number of events 14 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.8%
4/221 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.8%
4/219 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.2%
17/324 • Number of events 26 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.2%
20/321 • Number of events 34 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.1%
2/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.8%
4/221 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.7%
6/219 • Number of events 6 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.0%
13/324 • Number of events 21 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
8.1%
26/321 • Number of events 35 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.7%
3/179 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.1%
9/221 • Number of events 10 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.3%
5/221 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.8%
22/324 • Number of events 24 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.7%
15/321 • Number of events 15 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Gastrointestinal disorders
NAUSEA
|
3.2%
7/221 • Number of events 8 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.8%
15/221 • Number of events 17 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.4%
3/219 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
9.3%
30/324 • Number of events 40 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.6%
18/321 • Number of events 20 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.6%
18/324 • Number of events 23 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.7%
15/321 • Number of events 20 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
BRONCHITIS
|
2.3%
5/221 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.8%
4/221 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.3%
5/219 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
10.8%
35/324 • Number of events 55 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
13.1%
42/321 • Number of events 58 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.1%
2/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
COVID-19
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.2%
20/324 • Number of events 21 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.62%
2/321 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
8.9%
16/179 • Number of events 16 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
HERPES ZOSTER
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
8.3%
27/324 • Number of events 29 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
13.7%
44/321 • Number of events 46 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.2%
4/179 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
INFLUENZA
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.4%
3/219 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.6%
15/324 • Number of events 18 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.9%
22/321 • Number of events 23 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.1%
9/221 • Number of events 10 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.4%
12/221 • Number of events 13 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.9%
13/219 • Number of events 14 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
18.5%
60/324 • Number of events 105 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
14.0%
45/321 • Number of events 75 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.7%
3/179 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.6%
18/324 • Number of events 19 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.8%
9/321 • Number of events 10 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
SINUSITIS
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.7%
6/221 • Number of events 6 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.46%
1/219 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
8.6%
28/324 • Number of events 40 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.9%
22/321 • Number of events 23 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.1%
9/221 • Number of events 10 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.4%
12/221 • Number of events 12 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.5%
12/219 • Number of events 13 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
19.8%
64/324 • Number of events 111 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
17.8%
57/321 • Number of events 84 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.2%
4/179 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.6%
8/221 • Number of events 8 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.6%
8/221 • Number of events 8 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.7%
6/219 • Number of events 6 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
17.0%
55/324 • Number of events 89 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
14.3%
46/321 • Number of events 71 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.2%
4/179 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Injury, poisoning and procedural complications
FALL
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.5%
21/324 • Number of events 28 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.3%
17/321 • Number of events 19 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.8%
5/179 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.3%
5/221 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.3%
5/219 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
11.1%
36/324 • Number of events 42 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
10.3%
33/321 • Number of events 41 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.1%
2/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.7%
6/221 • Number of events 6 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.4%
3/219 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
10.2%
33/324 • Number of events 44 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
7.8%
25/321 • Number of events 31 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.7%
3/179 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.3%
5/221 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.2%
7/219 • Number of events 7 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
11.1%
36/324 • Number of events 55 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
10.0%
32/321 • Number of events 46 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.7%
12/324 • Number of events 12 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
5.3%
17/321 • Number of events 17 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/221 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/219 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
7.1%
23/324 • Number of events 28 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.1%
10/321 • Number of events 10 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.56%
1/179 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.7%
6/221 • Number of events 7 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
9.6%
31/324 • Number of events 37 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.5%
21/321 • Number of events 22 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.7%
3/179 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
4.5%
10/221 • Number of events 11 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.8%
4/221 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.8%
4/219 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
11.1%
36/324 • Number of events 54 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
9.3%
30/321 • Number of events 41 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.5%
8/179 • Number of events 8 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Nervous system disorders
HEADACHE
|
5.4%
12/221 • Number of events 14 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.1%
9/221 • Number of events 9 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
3.7%
8/219 • Number of events 9 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.5%
21/324 • Number of events 24 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.5%
21/321 • Number of events 24 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.1%
2/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
4.1%
9/221 • Number of events 9 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.4%
3/219 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
7.4%
24/324 • Number of events 28 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
8.1%
26/321 • Number of events 33 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.00%
0/179 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.90%
2/221 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.45%
1/221 • Number of events 1 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.3%
5/219 • Number of events 5 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.9%
6/324 • Number of events 7 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
6.5%
21/321 • Number of events 23 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.1%
2/179 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
|
Vascular disorders
HYPERTENSION
|
1.8%
4/221 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
1.4%
3/221 • Number of events 3 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
0.91%
2/219 • Number of events 2 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
12.7%
41/324 • Number of events 45 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
8.4%
27/321 • Number of events 29 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
2.2%
4/179 • Number of events 4 • Period 1: From first dose of study drug (placebo or upadacitinib) up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 1+2: From first dose of upadacitinib up to 30 days after last dose (maximum of 264 weeks).
|
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