Trial Outcomes & Findings for A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (NCT NCT02629159)

NCT ID: NCT02629159

Last Updated: 2025-08-05

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

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

1629 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2025-08-05

Participant Flow

Participants with moderately to severely active rheumatoid arthritis (RA) on a stable dose of methotrexate with an inadequate response were randomized at 286 study sites in 41 countries. This study is currently ongoing; results are reported as of the data cut-off date of 02 February 2018, when all participants were to have completed Week 26.

Participants were randomized in a 2:1:2 ratio to receive placebo, adalimumab, or upadacitinib. Randomization was stratified by prior exposure to biologic disease-modifying anti-rheumatic drug(s) (bDMARD) (yes/no) and geographic region. Rescue therapy was offered to participants who met protocol-specified criteria at Weeks 14, 18, 22, or 26.

Participant milestones

Participant milestones
Measure
Placebo
Participants randomized to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were switched to 15 mg upadacitinib QD.
Adalimumab
Participants randomized to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index \[CDAI\] ≤ 10) were switched to 15 mg upadacitinib orally QD.
Upadacitinib
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were switched to 40 mg adalimumab eow.
Overall Study
STARTED
651
327
651
Overall Study
Received Assigned Study Drug
651
327
650
Overall Study
Completed Week 14 on Study Drug
620
300
620
Overall Study
Rescued at Week 14
231
56
78
Overall Study
Rescued at Week 18
48
14
29
Overall Study
Rescued at Week 22
26
7
18
Overall Study
COMPLETED
595
288
600
Overall Study
NOT COMPLETED
56
39
51

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo
Participants randomized to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were switched to 15 mg upadacitinib QD.
Adalimumab
Participants randomized to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index \[CDAI\] ≤ 10) were switched to 15 mg upadacitinib orally QD.
Upadacitinib
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were switched to 40 mg adalimumab eow.
Overall Study
Adverse Event
17
20
22
Overall Study
Withdrawal by Subject
22
11
15
Overall Study
Lost to Follow-up
7
4
5
Overall Study
Lack of Efficacy
4
0
1
Overall Study
Other
6
4
8

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Total
n=1629 Participants
Total of all reporting groups
Age, Continuous
53.6 years
STANDARD_DEVIATION 12.24 • n=651 Participants
53.7 years
STANDARD_DEVIATION 11.70 • n=327 Participants
54.2 years
STANDARD_DEVIATION 12.08 • n=651 Participants
53.9 years
STANDARD_DEVIATION 12.07 • n=1629 Participants
Age, Customized
< 40 years
91 Participants
n=651 Participants
39 Participants
n=327 Participants
81 Participants
n=651 Participants
211 Participants
n=1629 Participants
Age, Customized
40 to 64 years
437 Participants
n=651 Participants
232 Participants
n=327 Participants
439 Participants
n=651 Participants
1108 Participants
n=1629 Participants
Age, Customized
≥ 65 years
123 Participants
n=651 Participants
56 Participants
n=327 Participants
131 Participants
n=651 Participants
310 Participants
n=1629 Participants
Sex: Female, Male
Female
512 Participants
n=651 Participants
259 Participants
n=327 Participants
521 Participants
n=651 Participants
1292 Participants
n=1629 Participants
Sex: Female, Male
Male
139 Participants
n=651 Participants
68 Participants
n=327 Participants
130 Participants
n=651 Participants
337 Participants
n=1629 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
206 Participants
n=651 Participants
106 Participants
n=327 Participants
215 Participants
n=651 Participants
527 Participants
n=1629 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
445 Participants
n=651 Participants
221 Participants
n=327 Participants
436 Participants
n=651 Participants
1102 Participants
n=1629 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=651 Participants
0 Participants
n=327 Participants
0 Participants
n=651 Participants
0 Participants
n=1629 Participants
Race/Ethnicity, Customized
White
561 Participants
n=651 Participants
292 Participants
n=327 Participants
576 Participants
n=651 Participants
1429 Participants
n=1629 Participants
Race/Ethnicity, Customized
Black or African American
38 Participants
n=651 Participants
17 Participants
n=327 Participants
33 Participants
n=651 Participants
88 Participants
n=1629 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
2 Participants
n=651 Participants
1 Participants
n=327 Participants
1 Participants
n=651 Participants
4 Participants
n=1629 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
1 Participants
n=651 Participants
0 Participants
n=327 Participants
0 Participants
n=651 Participants
1 Participants
n=1629 Participants
Race/Ethnicity, Customized
Asian
39 Participants
n=651 Participants
15 Participants
n=327 Participants
31 Participants
n=651 Participants
85 Participants
n=1629 Participants
Race/Ethnicity, Customized
Multiple
10 Participants
n=651 Participants
2 Participants
n=327 Participants
10 Participants
n=651 Participants
22 Participants
n=1629 Participants
Geographic Region
North America
121 Participants
n=651 Participants
60 Participants
n=327 Participants
122 Participants
n=651 Participants
303 Participants
n=1629 Participants
Geographic Region
South/Central America
173 Participants
n=651 Participants
86 Participants
n=327 Participants
173 Participants
n=651 Participants
432 Participants
n=1629 Participants
Geographic Region
Western Europe
35 Participants
n=651 Participants
19 Participants
n=327 Participants
35 Participants
n=651 Participants
89 Participants
n=1629 Participants
Geographic Region
Eastern Europe
262 Participants
n=651 Participants
132 Participants
n=327 Participants
262 Participants
n=651 Participants
656 Participants
n=1629 Participants
Geographic Region
Asia
21 Participants
n=651 Participants
10 Participants
n=327 Participants
21 Participants
n=651 Participants
52 Participants
n=1629 Participants
Geographic Region
Other
39 Participants
n=651 Participants
20 Participants
n=327 Participants
38 Participants
n=651 Participants
97 Participants
n=1629 Participants
Duration of Rheumatoid Arthritis Diagnosis
8.3 years
STANDARD_DEVIATION 8.00 • n=651 Participants
8.3 years
STANDARD_DEVIATION 8.41 • n=327 Participants
8.1 years
STANDARD_DEVIATION 7.73 • n=651 Participants
8.2 years
STANDARD_DEVIATION 7.97 • n=1629 Participants
Tender Joint Count
26.0 tender joints
STANDARD_DEVIATION 14.30 • n=651 Participants
26.4 tender joints
STANDARD_DEVIATION 15.16 • n=327 Participants
26.4 tender joints
STANDARD_DEVIATION 15.15 • n=651 Participants
26.2 tender joints
STANDARD_DEVIATION 14.81 • n=1629 Participants
Swollen Joint Count
16.2 swollen joints
STANDARD_DEVIATION 8.97 • n=651 Participants
16.3 swollen joints
STANDARD_DEVIATION 9.19 • n=327 Participants
16.6 swollen joints
STANDARD_DEVIATION 10.31 • n=651 Participants
16.4 swollen joints
STANDARD_DEVIATION 9.57 • n=1629 Participants
Patient's Assessment of Pain
65.0 mm
STANDARD_DEVIATION 20.67 • n=649 Participants • Participants with available data
66.2 mm
STANDARD_DEVIATION 20.51 • n=325 Participants • Participants with available data
65.7 mm
STANDARD_DEVIATION 21.02 • n=647 Participants • Participants with available data
65.5 mm
STANDARD_DEVIATION 20.77 • n=1621 Participants • Participants with available data
Patient's Global Assessment of Disease Activity
63.8 mm
STANDARD_DEVIATION 21.49 • n=649 Participants • Participants with available data
65.8 mm
STANDARD_DEVIATION 21.08 • n=324 Participants • Participants with available data
64.3 mm
STANDARD_DEVIATION 21.83 • n=647 Participants • Participants with available data
64.4 mm
STANDARD_DEVIATION 21.55 • n=1620 Participants • Participants with available data
Physician's Global Assessment of Disease Activity
66.0 mm
STANDARD_DEVIATION 18.17 • n=620 Participants • Participants with available data
65.1 mm
STANDARD_DEVIATION 17.60 • n=305 Participants • Participants with available data
65.6 mm
STANDARD_DEVIATION 17.06 • n=616 Participants • Participants with available data
65.7 mm
STANDARD_DEVIATION 17.62 • n=1541 Participants • Participants with available data
Health Assessment Questionnaire - Disability Index (HAQ-DI)
1.6 units on a scale
STANDARD_DEVIATION 0.61 • n=649 Participants • Participants with available data
1.6 units on a scale
STANDARD_DEVIATION 0.59 • n=325 Participants • Participants with available data
1.6 units on a scale
STANDARD_DEVIATION 0.64 • n=646 Participants • Participants with available data
1.6 units on a scale
STANDARD_DEVIATION 0.62 • n=1620 Participants • Participants with available data
High-sensitivity C-reactive Protein (hsCRP)
18.0 mg/L
STANDARD_DEVIATION 21.52 • n=651 Participants
19.8 mg/L
STANDARD_DEVIATION 21.51 • n=327 Participants
17.9 mg/L
STANDARD_DEVIATION 22.49 • n=651 Participants
18.3 mg/L
STANDARD_DEVIATION 21.91 • n=1629 Participants
Disease Activity Score 28 Based on CRP (DAS28[CRP])
5.8 units on a scale
STANDARD_DEVIATION 0.94 • n=649 Participants • Participants with available data
5.9 units on a scale
STANDARD_DEVIATION 0.96 • n=324 Participants • Participants with available data
5.8 units on a scale
STANDARD_DEVIATION 0.97 • n=647 Participants • Participants with available data
5.8 units on a scale
STANDARD_DEVIATION 0.96 • n=1620 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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

Outcome measures
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
36.4 percentage of participants
Interval 32.7 to 40.1
63.0 percentage of participants
Interval 57.8 to 68.2
70.5 percentage of participants
Interval 67.0 to 74.0

PRIMARY outcome

Timeframe: Week 12

Population: 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 clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of \< 2.6 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 mm), 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 2.6 indicates clinical remission.

Outcome measures

Outcome measures
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
6.1 percentage of participants
Interval 4.3 to 8.0
18.0 percentage of participants
Interval 13.9 to 22.2
28.7 percentage of participants
Interval 25.2 to 32.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline 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 mm), 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

Outcome measures
Measure
Placebo
n=643 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=319 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=634 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in DAS28 (CRP) at Week 12
-1.15 units on a scale
Interval -1.276 to -1.017
-2.01 units on a scale
Interval -2.175 to -1.848
-2.48 units on a scale
Interval -2.608 to -2.347

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 26 or who were rescued prior to Week 26.

The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score. Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst). JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst). The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression.

Outcome measures

Outcome measures
Measure
Placebo
n=599 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=296 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=593 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
0.92 units on a scale
Interval 0.64 to 1.2
0.10 units on a scale
Interval -0.25 to 0.46
0.24 units on a scale
Interval -0.04 to 0.53

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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

Outcome measures
Measure
Placebo
n=648 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=324 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=644 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
-0.28 units on a scale
Interval -0.339 to -0.227
-0.49 units on a scale
Interval -0.556 to -0.415
-0.60 units on a scale
Interval -0.653 to -0.538

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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

Outcome measures
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
14.9 percentage of participants
Interval 12.2 to 17.6
29.1 percentage of participants
Interval 24.1 to 34.0
45.2 percentage of participants
Interval 41.3 to 49.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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 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

Outcome measures
Measure
Placebo
n=616 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=309 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=616 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
3.56 units on a scale
Interval 2.79 to 4.33
6.27 units on a scale
Interval 5.31 to 7.23
7.89 units on a scale
Interval 7.11 to 8.68

SECONDARY outcome

Timeframe: Week 12

Population: 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 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 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
13.8 percentage of participants
Interval 11.2 to 16.5
28.7 percentage of participants
Interval 23.8 to 33.7
45.0 percentage of participants
Interval 41.2 to 48.8

SECONDARY outcome

Timeframe: Week 12

Population: 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

Outcome measures
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
16.3 percentage of participants
Interval 13.4 to 19.1
30.0 percentage of participants
Interval 25.0 to 34.9
40.4 percentage of participants
Interval 36.6 to 44.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=619 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=306 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=618 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in Duration of Morning Stiffness at Week 12
-48.59 minutes
Interval -58.84 to -38.34
-82.71 minutes
Interval -95.8 to -69.62
-92.63 minutes
Interval -103.03 to -82.23

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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 four point Likert scale. 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

Outcome measures
Measure
Placebo
n=613 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=307 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=612 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
4.81 units on a scale
Interval 3.85 to 5.77
7.44 units on a scale
Interval 6.25 to 8.64
8.95 units on a scale
Interval 7.98 to 9.93

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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 severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=616 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=307 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=614 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Change From Baseline in Patient's Assessment of Pain at Week 12
-15.46 mm
Interval -17.63 to -13.29
-25.31 mm
Interval -28.16 to -22.47
-31.76 mm
Interval -33.96 to -29.56

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 26 or who were rescued prior to Week 26.

No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst). Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst). Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

Outcome measures

Outcome measures
Measure
Placebo
n=599 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=296 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=593 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants With No Radiographic Progression at Week 26
76.0 percentage of participants
Interval 72.5 to 79.4
86.8 percentage of participants
Interval 83.0 to 90.7
83.5 percentage of participants
Interval 80.5 to 86.5

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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

Outcome measures
Measure
Placebo
n=651 Participants
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Adalimumab
n=327 Participants
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD.
Upadacitinib
n=651 Participants
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow.
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
4.9 percentage of participants
Interval 3.3 to 6.6
13.5 percentage of participants
Interval 9.8 to 17.2
24.9 percentage of participants
Interval 21.6 to 28.2

Adverse Events

Placebo

Serious events: 19 serious events
Other events: 43 other events
Deaths: 2 deaths

Adalimumab

Serious events: 14 serious events
Other events: 16 other events
Deaths: 2 deaths

Upadacitinib

Serious events: 24 serious events
Other events: 72 other events
Deaths: 0 deaths

Placebo / Upadacitinib

Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths

Adalimumab / Upadacitinib

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Upadacitinib / Adalimumab

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo
n=652 participants at risk
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued.
Adalimumab
n=327 participants at risk
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued.
Upadacitinib
n=650 participants at risk
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow. Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued.
Placebo / Upadacitinib
n=304 participants at risk
Participants who originally received placebo were switched at Weeks 14, 18, or 22 to receive 15 mg upadacitinib orally QD. Includes all events that occurred after the switch to rescue treatment up to Week 26.
Adalimumab / Upadacitinib
n=77 participants at risk
Participants who originally received adalimumab were switched at Weeks 14, 18, or 22 to receive 15 mg upadacitinib orally QD. Includes all events that occurred after the switch to rescue treatment up to Week 26.
Upadacitinib / Adalimumab
n=125 participants at risk
Participants who originally received 15 mg upadacitinib QD were switched at Weeks 14, 18, or 22 to receive 40 mg adalimumab eow. Includes all events that occurred after the switch to rescue treatment up to Week 26.
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Cardiac disorders
ATRIAL FLUTTER
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Cardiac disorders
CARDIAC FAILURE
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Cardiac disorders
CARDIOGENIC SHOCK
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Cardiac disorders
LEFT VENTRICULAR FAILURE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Cardiac disorders
MYOCARDIAL INFARCTION
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Cardiac disorders
RIGHT VENTRICULAR DILATATION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Eye disorders
CATARACT
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Gastrointestinal disorders
DIARRHOEA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 2 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Gastrointestinal disorders
FOOD POISONING
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Gastrointestinal disorders
GASTRIC POLYPS
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
General disorders
PYREXIA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
General disorders
SUDDEN DEATH
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Hepatobiliary disorders
CHOLELITHIASIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Hepatobiliary disorders
HEPATITIS TOXIC
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
APPENDICITIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
2/650 • Number of events 2 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
BRONCHIOLITIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
BRONCHITIS BACTERIAL
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
CELLULITIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.61%
2/327 • Number of events 2 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
FALLOPIAN TUBE ABSCESS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
GASTROENTERITIS
0.46%
3/652 • Number of events 3 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
2/650 • Number of events 2 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
INFECTED BITE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
INFECTIOUS COLITIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
INFLUENZA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
KIDNEY INFECTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
LUNG INFECTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
PERITONITIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
0.31%
2/652 • Number of events 2 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
PNEUMONIA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.80%
1/125 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
PYELONEPHRITIS ACUTE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
SEPSIS
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
SOFT TISSUE INFECTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
UROSEPSIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
VIRAL INFECTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
AIRWAY COMPLICATION OF ANAESTHESIA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
FALL
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
FIBULA FRACTURE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
HEAD INJURY
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
HIP FRACTURE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
TIBIA FRACTURE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Musculoskeletal and connective tissue disorders
ARTHRITIS
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Musculoskeletal and connective tissue disorders
NECK PAIN
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Musculoskeletal and connective tissue disorders
VERTEBRAL LESION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
DEMYELINATION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
DIZZINESS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
NEUROTOXICITY
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
PARAPLEGIA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
SEIZURE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.33%
1/304 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
SPINAL CORD HAEMORRHAGE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Nervous system disorders
SYNCOPE
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
2/650 • Number of events 2 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Psychiatric disorders
CONFUSIONAL STATE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Renal and urinary disorders
BLADDER PROLAPSE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Renal and urinary disorders
RENAL FAILURE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Reproductive system and breast disorders
MENORRHAGIA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.80%
1/125 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Respiratory, thoracic and mediastinal disorders
ASTHMA
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Respiratory, thoracic and mediastinal disorders
IDIOPATHIC PULMONARY FIBROSIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
0.15%
1/652 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.92%
3/327 • Number of events 3 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.15%
1/650 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.31%
1/327 • Number of events 1 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.

Other adverse events

Other adverse events
Measure
Placebo
n=652 participants at risk
Participants received placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued.
Adalimumab
n=327 participants at risk
Participants received placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 15 mg upadacitinib orally QD. Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued.
Upadacitinib
n=650 participants at risk
Participants randomized to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were switched to 40 mg adalimumab eow. Includes events up to the time of rescue (at Weeks 14, 18, 22) or up to Week 26 for those who were not rescued.
Placebo / Upadacitinib
n=304 participants at risk
Participants who originally received placebo were switched at Weeks 14, 18, or 22 to receive 15 mg upadacitinib orally QD. Includes all events that occurred after the switch to rescue treatment up to Week 26.
Adalimumab / Upadacitinib
n=77 participants at risk
Participants who originally received adalimumab were switched at Weeks 14, 18, or 22 to receive 15 mg upadacitinib orally QD. Includes all events that occurred after the switch to rescue treatment up to Week 26.
Upadacitinib / Adalimumab
n=125 participants at risk
Participants who originally received 15 mg upadacitinib QD were switched at Weeks 14, 18, or 22 to receive 40 mg adalimumab eow. Includes all events that occurred after the switch to rescue treatment up to Week 26.
Infections and infestations
NASOPHARYNGITIS
2.9%
19/652 • Number of events 20 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
2.8%
9/327 • Number of events 10 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
5.5%
36/650 • Number of events 42 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
3.7%
24/652 • Number of events 24 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
2.1%
7/327 • Number of events 8 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
5.7%
37/650 • Number of events 43 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/304 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/77 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/125 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
Infections and infestations
URINARY TRACT INFECTION
0.00%
0/652 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/327 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
0.00%
0/650 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
3.0%
9/304 • Number of events 9 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
7.8%
6/77 • Number of events 6 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.
3.2%
4/125 • Number of events 4 • From first dose of study drug up to Week 26, or up to 30 days after last dose for those receiving placebo or upadacitinib who discontinued prior to Week 26, or up to 70 days after last dose for those receiving adalimumab who discontinued prior to Week 26.
One participant randomized to upadacitinib received placebo to adalimumab but did not receive upadacitinib and is counted in the placebo group for analyses of safety. One participant who switched from placebo to upadacitinib at Week 18 did not receive any upadacitinib and is therefore not counted in the placebo / upadacitinib treatment group.

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