Trial Outcomes & Findings for A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate (NCT NCT02706873)
NCT ID: NCT02706873
Last Updated: 2023-07-07
Results Overview
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. 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).
COMPLETED
PHASE3
1002 participants
Baseline and Week 12
2023-07-07
Participant Flow
Participants were randomized at 236 sites in 43 countries. The study included 2 periods and a Japan sub-study. The global study analysis included participants from Japan, but excluded the upadacitinib 7.5 mg group. The Japan sub-study included all participants from Japan, including the upadacitinib 7.5 mg group.
Participants were randomized in a 1:1:1 ratio to Groups 1, 3, and 4 below, except for participants in Japan who were randomized in a 1:2:1:1 ratio to Groups 1, 2, 3, and 4. Randomization was stratified by geographic region. Efficacy analyses were conducted separately for the Japan sub-study.
Participant milestones
| Measure |
Methotrexate
Group 1 participants received up to 20 mg methotrexate orally per week (15 mg/week in China and Japan) and placebo to upadacitinib once a day (QD) for 48 weeks during Period 1.
Participants who did not achieve Clinical Remission (CR) based on clinical disease activity index (CDAI) score (CDAI ≤ 2.8) and did not achieve a ≥ 20% improvement from Baseline in both tender joint count (TJC) and swollen joint count (SJC) at Week 26 were re-randomized in a 1:1 ratio to receive rescue therapy with upadacitinib 15 mg or 30 mg QD (or in a 1:1:1 ratio to receive upadacitinib 7.5 mg, 15 mg, or 30 mg QD for participants in Japan) in addition to methotrexate.
In Period 2 (Weeks 48 to 260) participants continued to receive the treatment they were assigned at the end of Period 1.
|
Upadacitinib 7.5 mg
Group 2 participants (Japan only) received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
Participants who did not achieve CR based on CDAI and did not achieve a ≥ 20% improvement from Baseline in both TJC and SJC at Week 26 received rescue treatment with methotrexate 7.5 mg/week in addition to continuing to receive upadacitinib 7.5 mg QD.
In Period 2 participants continued to receive the treatment they were assigned at the end of Period 1.
|
Upadacitinib 15 mg
Group 3 participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
Participants who did not achieve CR based on CDAI and did not achieve a ≥ 20% improvement from Baseline in both TJC and SJC at Week 26 received rescue treatment with methotrexate 10 mg/week (7.5 mg for China and Japan) in addition to continuing to receive upadacitinib 15 mg QD.
In Period 2 participants continued to receive the treatment they were assigned at the end of Period 1 up to Week 260.
|
Upadacitinib 30 mg
Group 4 participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
Participants who did not achieve CR by CDAI and did not achieve a ≥ 20% improvement from Baseline in both TJC and SJC at Week 26 received rescue treatment with methotrexate 10 mg/week (7.5 mg for China and Japan) in addition to continuing to receive upadacitinib 30 mg QD.
In Period 2 participants continued to receive the treatment they were assigned at the end of Period 1. Starting with Protocol Amendment 6 participants were switched to receive open-label upadacitinib 15 mg QD.
|
|---|---|---|---|---|
|
Period 1 (Weeks 1 to 48)
STARTED
|
315
|
55
|
317
|
315
|
|
Period 1 (Weeks 1 to 48)
Received Study Drug
|
314
|
55
|
317
|
314
|
|
Period 1 (Weeks 1 to 48)
Global Analysis Population
|
314
|
0
|
317
|
314
|
|
Period 1 (Weeks 1 to 48)
Japan Sub-study
|
28
|
55
|
27
|
28
|
|
Period 1 (Weeks 1 to 48)
Completed Week 24 Study Drug
|
268
|
51
|
290
|
282
|
|
Period 1 (Weeks 1 to 48)
Received Combination Rescue Therapy at Week 26
|
37
|
3
|
19
|
9
|
|
Period 1 (Weeks 1 to 48)
COMPLETED
|
256
|
51
|
277
|
271
|
|
Period 1 (Weeks 1 to 48)
NOT COMPLETED
|
59
|
4
|
40
|
44
|
|
Period 2 (Weeks 48 to 260)
STARTED
|
253
|
50
|
275
|
268
|
|
Period 2 (Weeks 48 to 260)
Received Study Drug
|
242
|
48
|
273
|
260
|
|
Period 2 (Weeks 48 to 260)
COMPLETED
|
163
|
40
|
217
|
187
|
|
Period 2 (Weeks 48 to 260)
NOT COMPLETED
|
90
|
10
|
58
|
81
|
Reasons for withdrawal
| Measure |
Methotrexate
Group 1 participants received up to 20 mg methotrexate orally per week (15 mg/week in China and Japan) and placebo to upadacitinib once a day (QD) for 48 weeks during Period 1.
Participants who did not achieve Clinical Remission (CR) based on clinical disease activity index (CDAI) score (CDAI ≤ 2.8) and did not achieve a ≥ 20% improvement from Baseline in both tender joint count (TJC) and swollen joint count (SJC) at Week 26 were re-randomized in a 1:1 ratio to receive rescue therapy with upadacitinib 15 mg or 30 mg QD (or in a 1:1:1 ratio to receive upadacitinib 7.5 mg, 15 mg, or 30 mg QD for participants in Japan) in addition to methotrexate.
In Period 2 (Weeks 48 to 260) participants continued to receive the treatment they were assigned at the end of Period 1.
|
Upadacitinib 7.5 mg
Group 2 participants (Japan only) received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
Participants who did not achieve CR based on CDAI and did not achieve a ≥ 20% improvement from Baseline in both TJC and SJC at Week 26 received rescue treatment with methotrexate 7.5 mg/week in addition to continuing to receive upadacitinib 7.5 mg QD.
In Period 2 participants continued to receive the treatment they were assigned at the end of Period 1.
|
Upadacitinib 15 mg
Group 3 participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
Participants who did not achieve CR based on CDAI and did not achieve a ≥ 20% improvement from Baseline in both TJC and SJC at Week 26 received rescue treatment with methotrexate 10 mg/week (7.5 mg for China and Japan) in addition to continuing to receive upadacitinib 15 mg QD.
In Period 2 participants continued to receive the treatment they were assigned at the end of Period 1 up to Week 260.
|
Upadacitinib 30 mg
Group 4 participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
Participants who did not achieve CR by CDAI and did not achieve a ≥ 20% improvement from Baseline in both TJC and SJC at Week 26 received rescue treatment with methotrexate 10 mg/week (7.5 mg for China and Japan) in addition to continuing to receive upadacitinib 30 mg QD.
In Period 2 participants continued to receive the treatment they were assigned at the end of Period 1. Starting with Protocol Amendment 6 participants were switched to receive open-label upadacitinib 15 mg QD.
|
|---|---|---|---|---|
|
Period 1 (Weeks 1 to 48)
Adverse Event
|
15
|
3
|
18
|
11
|
|
Period 1 (Weeks 1 to 48)
Withdrawal by Subject
|
22
|
0
|
12
|
20
|
|
Period 1 (Weeks 1 to 48)
Lost to Follow-up
|
4
|
0
|
6
|
5
|
|
Period 1 (Weeks 1 to 48)
Lack of Efficacy
|
12
|
0
|
2
|
4
|
|
Period 1 (Weeks 1 to 48)
Other
|
5
|
1
|
2
|
3
|
|
Period 1 (Weeks 1 to 48)
Not Dosed
|
1
|
0
|
0
|
1
|
|
Period 2 (Weeks 48 to 260)
Adverse Event
|
16
|
4
|
11
|
26
|
|
Period 2 (Weeks 48 to 260)
Withdrawal by Subject
|
32
|
5
|
23
|
27
|
|
Period 2 (Weeks 48 to 260)
Lost to Follow-up
|
17
|
0
|
10
|
6
|
|
Period 2 (Weeks 48 to 260)
Lack of Efficacy
|
11
|
0
|
1
|
1
|
|
Period 2 (Weeks 48 to 260)
Coronavirus Disease of 2019 (COVID-19) Infection
|
0
|
0
|
0
|
3
|
|
Period 2 (Weeks 48 to 260)
COVID-19 Logistic Restrictions
|
0
|
0
|
2
|
1
|
|
Period 2 (Weeks 48 to 260)
Other
|
14
|
1
|
11
|
17
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 7.5 mg
n=55 Participants
Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 12.89 • n=314 Participants
|
59.7 years
STANDARD_DEVIATION 13.8 • n=55 Participants
|
51.9 years
STANDARD_DEVIATION 12.58 • n=317 Participants
|
54.9 years
STANDARD_DEVIATION 12.58 • n=314 Participants
|
53.7 years
STANDARD_DEVIATION 12.86 • n=1000 Participants
|
|
Age, Customized
< 40 years
|
50 Participants
n=314 Participants
|
5 Participants
n=55 Participants
|
60 Participants
n=317 Participants
|
34 Participants
n=314 Participants
|
149 Participants
n=1000 Participants
|
|
Age, Customized
40 - 65 years
|
206 Participants
n=314 Participants
|
25 Participants
n=55 Participants
|
204 Participants
n=317 Participants
|
212 Participants
n=314 Participants
|
647 Participants
n=1000 Participants
|
|
Age, Customized
≥ 65 years
|
58 Participants
n=314 Participants
|
25 Participants
n=55 Participants
|
53 Participants
n=317 Participants
|
68 Participants
n=314 Participants
|
204 Participants
n=1000 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=314 Participants
|
36 Participants
n=55 Participants
|
241 Participants
n=317 Participants
|
240 Participants
n=314 Participants
|
757 Participants
n=1000 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=314 Participants
|
19 Participants
n=55 Participants
|
76 Participants
n=317 Participants
|
74 Participants
n=314 Participants
|
243 Participants
n=1000 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
102 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
107 Participants
n=317 Participants
|
107 Participants
n=314 Participants
|
316 Participants
n=1000 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=314 Participants
|
55 Participants
n=55 Participants
|
210 Participants
n=317 Participants
|
207 Participants
n=314 Participants
|
684 Participants
n=1000 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=317 Participants
|
0 Participants
n=314 Participants
|
0 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
White
|
256 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
256 Participants
n=317 Participants
|
254 Participants
n=314 Participants
|
766 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
8 Participants
n=317 Participants
|
13 Participants
n=314 Participants
|
33 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
2 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
8 Participants
n=317 Participants
|
7 Participants
n=314 Participants
|
17 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
3 Participants
n=317 Participants
|
1 Participants
n=314 Participants
|
6 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Asian
|
37 Participants
n=314 Participants
|
55 Participants
n=55 Participants
|
35 Participants
n=317 Participants
|
34 Participants
n=314 Participants
|
161 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
5 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
7 Participants
n=317 Participants
|
5 Participants
n=314 Participants
|
17 Participants
n=1000 Participants
|
|
Geographic Region
North America
|
46 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
48 Participants
n=317 Participants
|
46 Participants
n=314 Participants
|
140 Participants
n=1000 Participants
|
|
Geographic Region
South/Central America
|
90 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
91 Participants
n=317 Participants
|
91 Participants
n=314 Participants
|
272 Participants
n=1000 Participants
|
|
Geographic Region
Western Europe
|
37 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
36 Participants
n=317 Participants
|
36 Participants
n=314 Participants
|
109 Participants
n=1000 Participants
|
|
Geographic Region
Eastern Europe
|
85 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
87 Participants
n=317 Participants
|
87 Participants
n=314 Participants
|
259 Participants
n=1000 Participants
|
|
Geographic Region
Asia-Japan
|
28 Participants
n=314 Participants
|
55 Participants
n=55 Participants
|
27 Participants
n=317 Participants
|
28 Participants
n=314 Participants
|
138 Participants
n=1000 Participants
|
|
Geographic Region
Asia - China
|
1 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=317 Participants
|
1 Participants
n=314 Participants
|
3 Participants
n=1000 Participants
|
|
Geographic Region
Asia - Other
|
3 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
4 Participants
n=317 Participants
|
2 Participants
n=314 Participants
|
9 Participants
n=1000 Participants
|
|
Geographic Region
Other
|
24 Participants
n=314 Participants
|
0 Participants
n=55 Participants
|
23 Participants
n=317 Participants
|
23 Participants
n=314 Participants
|
70 Participants
n=1000 Participants
|
|
Duration of Rheumatoid Arthritis Diagnosis
|
2.6 years
STANDARD_DEVIATION 5.14 • n=314 Participants
|
2.3 years
STANDARD_DEVIATION 5.77 • n=55 Participants
|
2.9 years
STANDARD_DEVIATION 5.38 • n=317 Participants
|
2.8 years
STANDARD_DEVIATION 5.63 • n=314 Participants
|
2.7 years
STANDARD_DEVIATION 5.40 • n=1000 Participants
|
|
Tender Joint Count
|
26.4 tender joints
STANDARD_DEVIATION 16.15 • n=314 Participants
|
18.0 tender joints
STANDARD_DEVIATION 11.75 • n=55 Participants
|
25.4 tender joints
STANDARD_DEVIATION 14.42 • n=317 Participants
|
25.2 tender joints
STANDARD_DEVIATION 14.99 • n=314 Participants
|
25.3 tender joints
STANDARD_DEVIATION 15.12 • n=1000 Participants
|
|
Swollen Joint Count
|
16.9 swollen joints
STANDARD_DEVIATION 10.58 • n=314 Participants
|
14.7 swollen joints
STANDARD_DEVIATION 8.24 • n=55 Participants
|
16.9 swollen joints
STANDARD_DEVIATION 10.35 • n=317 Participants
|
15.7 swollen joints
STANDARD_DEVIATION 9.71 • n=314 Participants
|
16.4 swollen joints
STANDARD_DEVIATION 10.13 • n=1000 Participants
|
|
Patient's Assessment of Pain
|
65.7 mm
STANDARD_DEVIATION 21.46 • n=314 Participants • Participants with available data
|
64.1 mm
STANDARD_DEVIATION 21.20 • n=55 Participants • Participants with available data
|
68.4 mm
STANDARD_DEVIATION 20.60 • n=317 Participants • Participants with available data
|
65.3 mm
STANDARD_DEVIATION 21.51 • n=311 Participants • Participants with available data
|
66.3 mm
STANDARD_DEVIATION 21.21 • n=997 Participants • Participants with available data
|
|
Patient's Global Assessment of Disease Activity
|
65.8 mm
STANDARD_DEVIATION 21.45 • n=314 Participants • Participants with available data
|
64.1 mm
STANDARD_DEVIATION 21.36 • n=55 Participants • Participants with available data
|
66.6 mm
STANDARD_DEVIATION 22.01 • n=317 Participants • Participants with available data
|
64.9 mm
STANDARD_DEVIATION 21.63 • n=311 Participants • Participants with available data
|
65.7 mm
STANDARD_DEVIATION 21.66 • n=997 Participants • Participants with available data
|
|
Physician's Global Assessment of Disease Activity
|
68.7 mm
STANDARD_DEVIATION 16.45 • n=299 Participants • Participants with available data
|
63.3 mm
STANDARD_DEVIATION 19.34 • n=54 Participants • Participants with available data
|
67.1 mm
STANDARD_DEVIATION 17.00 • n=301 Participants • Participants with available data
|
65.3 mm
STANDARD_DEVIATION 16.60 • n=304 Participants • Participants with available data
|
66.8 mm
STANDARD_DEVIATION 16.89 • n=958 Participants • Participants with available data
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.6 units on a scale
STANDARD_DEVIATION 0.67 • n=314 Participants • Participants with available data
|
1.3 units on a scale
STANDARD_DEVIATION 0.62 • n=55 Participants • Participants with available data
|
1.6 units on a scale
STANDARD_DEVIATION 0.67 • n=317 Participants • Participants with available data
|
1.5 units on a scale
STANDARD_DEVIATION 0.66 • n=311 Participants • Participants with available data
|
1.6 units on a scale
STANDARD_DEVIATION 0.66 • n=997 Participants • Participants with available data
|
|
High-sensitivity C-reactive Protein (hsCRP)
|
21.2 mg/L
STANDARD_DEVIATION 22.05 • n=314 Participants
|
18.5 mg/L
STANDARD_DEVIATION 17.55 • n=55 Participants
|
23.0 mg/L
STANDARD_DEVIATION 27.37 • n=317 Participants
|
19.4 mg/L
STANDARD_DEVIATION 22.59 • n=314 Participants
|
21.0 mg/L
STANDARD_DEVIATION 23.84 • n=1000 Participants
|
|
Disease Activity Score 28 Based on CRP (DAS28[CRP])
|
5.9 units on a scale
STANDARD_DEVIATION 0.97 • n=314 Participants • Participants with available data
|
5.5 units on a scale
STANDARD_DEVIATION 0.90 • n=55 Participants • Participants with available data
|
5.9 units on a scale
STANDARD_DEVIATION 0.97 • n=317 Participants • Participants with available data
|
5.8 units on a scale
STANDARD_DEVIATION 1.02 • n=311 Participants • Participants with available data
|
5.8 units on a scale
STANDARD_DEVIATION 0.99 • n=997 Participants • Participants with available data
|
|
Modified Total Sharp Score (mTSS)
|
13.3 units on a scale
STANDARD_DEVIATION 30.55 • n=309 Participants • Participants with available data
|
15.9 units on a scale
STANDARD_DEVIATION 39.10 • n=55 Participants • Participants with available data
|
18.1 units on a scale
STANDARD_DEVIATION 38.15 • n=309 Participants • Participants with available data
|
17.2 units on a scale
STANDARD_DEVIATION 38.25 • n=309 Participants • Participants with available data
|
16.1 units on a scale
STANDARD_DEVIATION 36.02 • n=982 Participants • Participants with available data
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. The global analysis includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis
|
28.3 percentage of participants
Interval 23.4 to 33.3
|
52.1 percentage of participants
Interval 46.6 to 57.5
|
56.4 percentage of participants
Interval 50.9 to 61.9
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom DAS28 data were missing at Week 24 were considered non-responders. The global analysis includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
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 24. 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
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis
|
18.5 percentage of participants
Interval 14.2 to 22.8
|
48.3 percentage of participants
Interval 42.8 to 53.8
|
50.0 percentage of participants
Interval 44.5 to 55.5
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. The global analysis includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The primary endpoint for Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis
|
54.1 percentage of participants
Interval 48.6 to 59.7
|
75.7 percentage of participants
Interval 71.0 to 80.4
|
77.1 percentage of participants
Interval 72.4 to 81.7
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The second primary endpoint for Japan/PMDA regulatory purposes was change from baseline in mTSS at Week 24. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers. Joint erosion was assessed in 16 joints in each hand/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 change from Baseline greater than 0 indicates progression.
Outcome measures
| Measure |
Methotrexate
n=264 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=279 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=270 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis
|
0.67 units on a scale
Interval 0.43 to 0.9
|
0.14 units on a scale
Interval -0.09 to 0.37
|
0.07 units on a scale
Interval -0.16 to 0.31
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
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
| Measure |
Methotrexate
n=312 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=310 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis
|
-1.85 scores on a scale
Interval -2.0 to -1.69
|
-2.73 scores on a scale
Interval -2.87 to -2.58
|
-2.85 scores on a scale
Interval -3.0 to -2.7
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Methotrexate
n=313 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=310 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis
|
-0.49 scores on a scale
Interval -0.55 to -0.42
|
-0.83 scores on a scale
Interval -0.9 to -0.76
|
-0.86 scores on a scale
Interval -0.93 to -0.79
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
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
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis
|
28.3 percentage of participants
Interval 23.4 to 33.3
|
53.3 percentage of participants
Interval 47.8 to 58.8
|
54.8 percentage of participants
Interval 49.3 to 60.3
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Outcome measures
| Measure |
Methotrexate
n=311 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=315 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=311 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis
|
5.74 scores on a scale
Interval 4.84 to 6.64
|
9.99 scores on a scale
Interval 9.11 to 10.88
|
10.08 scores on a scale
Interval 9.19 to 10.98
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
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
| Measure |
Methotrexate
n=312 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=310 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis
|
-2.15 scores on a scale
Interval -2.31 to -1.99
|
-3.07 scores on a scale
Interval -3.21 to -2.92
|
-3.34 scores on a scale
Interval -3.49 to -3.19
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Methotrexate
n=313 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=310 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis
|
-0.60 scores on a scale
Interval -0.67 to -0.52
|
-0.87 scores on a scale
Interval -0.94 to -0.8
|
-0.91 scores on a scale
Interval -0.98 to -0.84
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom ACR data were missing at Week 24 were considered non-responders. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis
|
33.4 percentage of participants
Interval 28.2 to 38.7
|
60.3 percentage of participants
Interval 54.9 to 65.6
|
65.6 percentage of participants
Interval 60.4 to 70.9
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom DAS28 data were missing at Week 24 were considered non-responders. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
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
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis
|
32.2 percentage of participants
Interval 27.0 to 37.3
|
59.9 percentage of participants
Interval 54.5 to 65.3
|
65.0 percentage of participants
Interval 59.7 to 70.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Outcome measures
| Measure |
Methotrexate
n=313 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=315 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=312 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis
|
6.97 scores on a scale
Interval 6.03 to 7.91
|
10.70 scores on a scale
Interval 9.76 to 11.63
|
11.39 scores on a scale
Interval 10.42 to 12.36
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
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. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers. 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). The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Outcome measures
| Measure |
Methotrexate
n=264 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=279 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=270 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis
|
77.7 percentage of participants
Interval 72.6 to 82.7
|
87.5 percentage of participants
Interval 83.6 to 91.3
|
89.3 percentage of participants
Interval 85.6 to 93.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis
|
14.0 percentage of participants
Interval 10.2 to 17.9
|
32.5 percentage of participants
Interval 27.3 to 37.6
|
36.9 percentage of participants
Interval 31.6 to 42.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom ACR data were missing at Week 24 were considered non-responders. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis
|
58.6 percentage of participants
Interval 53.2 to 64.0
|
78.9 percentage of participants
Interval 74.4 to 83.4
|
78.0 percentage of participants
Interval 73.4 to 82.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom ACR data were missing at Week 24 were considered non-responders. The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=314 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=317 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=314 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis
|
18.5 percentage of participants
Interval 14.2 to 22.8
|
44.5 percentage of participants
Interval 39.0 to 49.9
|
49.7 percentage of participants
Interval 44.2 to 55.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study
|
57.1 percentage of participants
Interval 38.8 to 75.5
|
85.5 percentage of participants
Interval 76.1 to 94.8
|
85.2 percentage of participants
Interval 71.8 to 98.6
|
78.6 percentage of participants
Interval 63.4 to 93.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study
|
21.4 percentage of participants
Interval 6.2 to 36.6
|
60.0 percentage of participants
Interval 47.1 to 72.9
|
66.7 percentage of participants
Interval 48.9 to 84.4
|
71.4 percentage of participants
Interval 54.7 to 88.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
34.5 percentage of participants
Interval 22.0 to 47.1
|
51.9 percentage of participants
Interval 33.0 to 70.7
|
64.3 percentage of participants
Interval 46.5 to 82.0
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
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
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study
|
-1.42 scores on a scale
Interval -1.82 to -1.03
|
-2.86 scores on a scale
Interval -3.14 to -2.58
|
-3.28 scores on a scale
Interval -3.68 to -2.89
|
-3.34 scores on a scale
Interval -3.74 to -2.95
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study
|
-0.20 scores on a scale
Interval -0.37 to -0.04
|
-0.75 scores on a scale
Interval -0.86 to -0.63
|
-0.95 scores on a scale
Interval -1.12 to -0.78
|
-0.95 scores on a scale
Interval -1.12 to -0.79
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set participants with available data at Baseline; multiple imputation was used for missing data. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Outcome measures
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study
|
2.87 scores on a scale
Interval 0.56 to 5.18
|
8.84 scores on a scale
Interval 7.18 to 10.5
|
10.79 scores on a scale
Interval 8.48 to 13.09
|
9.63 scores on a scale
Interval 7.13 to 12.13
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
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
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study
|
17.9 percentage of participants
Interval 3.7 to 32.0
|
69.1 percentage of participants
Interval 56.9 to 81.3
|
77.8 percentage of participants
Interval 62.1 to 93.5
|
78.6 percentage of participants
Interval 63.4 to 93.8
|
SECONDARY outcome
Timeframe: Week 24Population: 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 Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
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 score less than 2.6 indicates clinical remission.
Outcome measures
| Measure |
Methotrexate
n=28 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=55 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=27 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=28 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study
|
17.9 percentage of participants
Interval 3.7 to 32.0
|
67.3 percentage of participants
Interval 54.9 to 79.7
|
70.4 percentage of participants
Interval 53.1 to 87.6
|
82.1 percentage of participants
Interval 68.0 to 96.3
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers. Joint erosion was assessed in 16 joints in each hand/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 change from Baseline greater than 0 indicates progression.
Outcome measures
| Measure |
Methotrexate
n=26 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=51 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=26 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=24 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study
|
2.64 units on a scale
Interval 1.19 to 4.09
|
0.95 units on a scale
Interval -0.09 to 1.98
|
0.24 units on a scale
Interval -1.21 to 1.69
|
0.19 units on a scale
Interval -1.31 to 1.7
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24. The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups.
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. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers. 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). The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Outcome measures
| Measure |
Methotrexate
n=26 Participants
Participants received up to 20 mg methotrexate orally per week and placebo to upadacitinib once a day for 48 weeks during Period 1.
|
Upadacitinib 15 mg
n=51 Participants
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=26 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
Upadacitinib 30 mg
n=24 Participants
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 48 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study
|
46.2 percentage of participants
Interval 27.0 to 65.3
|
82.4 percentage of participants
Interval 71.9 to 92.8
|
80.8 percentage of participants
Interval 65.6 to 95.9
|
79.2 percentage of participants
Interval 62.9 to 95.4
|
Adverse Events
Weeks 1-24: Methotrexate Monotherapy
Weeks 1-24: Upadacitinib 7.5 mg Monotherapy
Weeks 1-24: Upadacitinib 15 mg Monotherapy
Weeks 1-24: Upadacitinib 30 mg Monotherapy
Weeks 1-260: Methotrexate Monotherapy
Weeks 1-260: Upadacitinib 7.5 mg Monotherapy
Weeks 1-260: Upadacitinib 15 mg Monotherapy
Weeks 1-260/Switch: Upadacitinib 30 mg Monotherapy
Weeks 1-260: Any Upadacitinib 7.5 mg
Weeks 1-260: Any Upadacitinib 15 mg
Weeks 1-260/Switch: Any Upadacitinib 30 mg
After Switch: Upadacitinib 15 mg Monotherapy
After Switch: Any Upadacitinib 15 mg
Serious adverse events
| Measure |
Weeks 1-24: Methotrexate Monotherapy
n=314 participants at risk
Participants received up to 20 mg methotrexate orally per week (15 mg/week in China and Japan) and placebo to upadacitinib QD for 24 weeks during Period 1.
|
Weeks 1-24: Upadacitinib 7.5 mg Monotherapy
n=55 participants at risk
Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 24 weeks in Period 1.
|
Weeks 1-24: Upadacitinib 15 mg Monotherapy
n=317 participants at risk
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 24 weeks in Period 1.
|
Weeks 1-24: Upadacitinib 30 mg Monotherapy
n=314 participants at risk
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 24 weeks in Period 1.
|
Weeks 1-260: Methotrexate Monotherapy
n=314 participants at risk
Participants received up to 20 mg methotrexate orally per week (15 mg/week in China and Japan) for 260 weeks. Includes events up until the addition of upadacitinib for participants who were rescued at Week 26.
|
Weeks 1-260: Upadacitinib 7.5 mg Monotherapy
n=55 participants at risk
Participants received 7.5 mg upadacitinib monotherapy once a day for 260 weeks. Includes events up until the addition of methotrexate or addition of background conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) for participants who received rescue.
|
Weeks 1-260: Upadacitinib 15 mg Monotherapy
n=317 participants at risk
Participants received 15 mg upadacitinib monotherapy once a day for 260 weeks. Includes events up until the addition of methotrexate or addition of background csDMARD for participants who received rescue.
|
Weeks 1-260/Switch: Upadacitinib 30 mg Monotherapy
n=314 participants at risk
Participants received 30 mg upadacitinib monotherapy once a day for 260 weeks or until implementation of Protocol Amendment 6 (December 2019) when they were switched to upadacitinib 15 mg. Includes events up until the addition of methotrexate or addition of background csDMARD for participants who received rescue, or up until the switch to upadacitinib 15 mg.
|
Weeks 1-260: Any Upadacitinib 7.5 mg
n=56 participants at risk
Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg QD for up to 260 weeks, including events after the addition of rescue therapy. Participants originally randomized to methotrexate and rescued at Week 26 to methotrexate plus upadacitinib 7.5 mg received upadacitinib 7.5 mg QD from Week 26 to Week 260.
|
Weeks 1-260: Any Upadacitinib 15 mg
n=335 participants at risk
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg QD for up to 260 weeks, including events after the addition of rescue therapy. Participants originally randomized to methotrexate and rescued at Week 26 to methotrexate plus upadacitinib 15 mg received upadacitinib 15 mg QD from Week 26 to Week 260.
|
Weeks 1-260/Switch: Any Upadacitinib 30 mg
n=332 participants at risk
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg QD for up to 260 weeks or until implementation of Protocol Amendment 6 (December 2019) when they were switched to upadacitinib 15 mg, including events after the addition of rescue therapy. Participants originally randomized to methotrexate and rescued at Week 26 to methotrexate plus upadacitinib 30 mg received upadacitinib 30 mg QD from Week 26 to Week 260 or until implementation of Protocol Amendment 6 when they were switched to methotrexate plus upadacitinib 15 mg. Includes events up until the switch to upadacitinib 15 mg.
|
After Switch: Upadacitinib 15 mg Monotherapy
n=181 participants at risk
Participants who were receiving upadacitinib 30 mg QD monotherapy in Period 2 were switched to receive upadacitinib 15 mg QD monotherapy after implementation of Protocol Amendment 6 (December 2019) up to Week 260.
|
After Switch: Any Upadacitinib 15 mg
n=218 participants at risk
Participants who were receiving any upadacitinib 30 mg QD (monotherapy or in combination with methotrexate or csDMARD after rescue) in Period 2 were switched to receive upadacitinib 15 mg QD (monotherapy or in combination with methotrexate or csDMARD if rescued) after implementation of Protocol Amendment 6 (December 2019) up to Week 260.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
METABOLIC CARDIOMYOPATHY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
MYOCARDIAL FIBROSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
SINUS NODE DYSFUNCTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Congenital, familial and genetic disorders
HAEMORRHAGIC ARTERIOVENOUS MALFORMATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
CATARACT
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
CATARACT DIABETIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
IRIDOCYCLITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
MACULAR HOLE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
VITREORETINAL TRACTION SYNDROME
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GASTRIC ULCER PERFORATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GINGIVAL RECESSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
PANCREATIC DISORDER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
RECTAL POLYP
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
SALIVARY GLAND CALCULUS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
CHEST PAIN
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
DEATH
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Hepatobiliary disorders
GALLBLADDER RUPTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
ACTINOMYCOTIC PULMONARY INFECTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
COVID-19
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/335 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.4%
8/181 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
12/218 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
CELLULITIS
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
CORONAVIRUS PNEUMONIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
EMPYEMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
FEMALE GENITAL TRACT TUBERCULOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
GALLBLADDER ABSCESS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
GENITAL HERPES SIMPLEX
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
HERPES ZOSTER DISSEMINATED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
HERPES ZOSTER MENINGITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
INFECTIVE SPONDYLITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
KERATITIS BACTERIAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
MENINGITIS BACTERIAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
OPHTHALMIC HERPES ZOSTER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PERITONEAL TUBERCULOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PNEUMONIA
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/335 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/332 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PNEUMONIA CRYPTOCOCCAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PNEUMONIA ESCHERICHIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PNEUMONIA KLEBSIELLA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PROSTATITIS ESCHERICHIA COLI
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PYELONEPHRITIS CHRONIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
Q FEVER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
SINOBRONCHITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
CORNEAL LACERATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
LIMB CRUSHING INJURY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
POST LUMBAR PUNCTURE SYNDROME
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL FISTULA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
ABNORMAL WEIGHT GAIN
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
CENTRAL OBESITY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
OBESITY
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
ACQUIRED CLAW TOE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
SUBCHONDRAL INSUFFICIENCY FRACTURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
SYMPATHETIC POSTERIOR CERVICAL SYNDROME
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA METASTATIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANGIOFIBROMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN OVARIAN TUMOUR
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA STAGE 0
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL ADENOCARCINOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FIBROMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEIOMYOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA METASTATIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PALATE NEOPLASM
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE TUMOUR
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER METASTATIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN GERM CELL TERATOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA STAGE I
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBACEOUS CARCINOMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF LUNG
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE TONGUE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CARCINOMA IN SITU
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
CAROTID ARTERIOSCLEROSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
CAROTID ARTERY DISEASE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
MONOPARESIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
MYELOPATHY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
SPONDYLITIC MYELOPATHY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/335 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
VERTEBROBASILAR INSUFFICIENCY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Psychiatric disorders
MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
RENAL CYST
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
BREAST HYPOPLASIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
CERVIX HAEMORRHAGE UTERINE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERPLASIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
MENOMETRORRHAGIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMATIC CRISIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX SPONTANEOUS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
EMBOLISM ARTERIAL
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
Other adverse events
| Measure |
Weeks 1-24: Methotrexate Monotherapy
n=314 participants at risk
Participants received up to 20 mg methotrexate orally per week (15 mg/week in China and Japan) and placebo to upadacitinib QD for 24 weeks during Period 1.
|
Weeks 1-24: Upadacitinib 7.5 mg Monotherapy
n=55 participants at risk
Participants received 7.5 mg upadacitinib orally once a day and placebo to methotrexate once a week for 24 weeks in Period 1.
|
Weeks 1-24: Upadacitinib 15 mg Monotherapy
n=317 participants at risk
Participants received 15 mg upadacitinib orally once a day and placebo to methotrexate once a week for 24 weeks in Period 1.
|
Weeks 1-24: Upadacitinib 30 mg Monotherapy
n=314 participants at risk
Participants received 30 mg upadacitinib orally once a day and placebo to methotrexate once a week for 24 weeks in Period 1.
|
Weeks 1-260: Methotrexate Monotherapy
n=314 participants at risk
Participants received up to 20 mg methotrexate orally per week (15 mg/week in China and Japan) for 260 weeks. Includes events up until the addition of upadacitinib for participants who were rescued at Week 26.
|
Weeks 1-260: Upadacitinib 7.5 mg Monotherapy
n=55 participants at risk
Participants received 7.5 mg upadacitinib monotherapy once a day for 260 weeks. Includes events up until the addition of methotrexate or addition of background conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) for participants who received rescue.
|
Weeks 1-260: Upadacitinib 15 mg Monotherapy
n=317 participants at risk
Participants received 15 mg upadacitinib monotherapy once a day for 260 weeks. Includes events up until the addition of methotrexate or addition of background csDMARD for participants who received rescue.
|
Weeks 1-260/Switch: Upadacitinib 30 mg Monotherapy
n=314 participants at risk
Participants received 30 mg upadacitinib monotherapy once a day for 260 weeks or until implementation of Protocol Amendment 6 (December 2019) when they were switched to upadacitinib 15 mg. Includes events up until the addition of methotrexate or addition of background csDMARD for participants who received rescue, or up until the switch to upadacitinib 15 mg.
|
Weeks 1-260: Any Upadacitinib 7.5 mg
n=56 participants at risk
Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg QD for up to 260 weeks, including events after the addition of rescue therapy. Participants originally randomized to methotrexate and rescued at Week 26 to methotrexate plus upadacitinib 7.5 mg received upadacitinib 7.5 mg QD from Week 26 to Week 260.
|
Weeks 1-260: Any Upadacitinib 15 mg
n=335 participants at risk
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg QD for up to 260 weeks, including events after the addition of rescue therapy. Participants originally randomized to methotrexate and rescued at Week 26 to methotrexate plus upadacitinib 15 mg received upadacitinib 15 mg QD from Week 26 to Week 260.
|
Weeks 1-260/Switch: Any Upadacitinib 30 mg
n=332 participants at risk
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg QD for up to 260 weeks or until implementation of Protocol Amendment 6 (December 2019) when they were switched to upadacitinib 15 mg, including events after the addition of rescue therapy. Participants originally randomized to methotrexate and rescued at Week 26 to methotrexate plus upadacitinib 30 mg received upadacitinib 30 mg QD from Week 26 to Week 260 or until implementation of Protocol Amendment 6 when they were switched to methotrexate plus upadacitinib 15 mg. Includes events up until the switch to upadacitinib 15 mg.
|
After Switch: Upadacitinib 15 mg Monotherapy
n=181 participants at risk
Participants who were receiving upadacitinib 30 mg QD monotherapy in Period 2 were switched to receive upadacitinib 15 mg QD monotherapy after implementation of Protocol Amendment 6 (December 2019) up to Week 260.
|
After Switch: Any Upadacitinib 15 mg
n=218 participants at risk
Participants who were receiving any upadacitinib 30 mg QD (monotherapy or in combination with methotrexate or csDMARD after rescue) in Period 2 were switched to receive upadacitinib 15 mg QD (monotherapy or in combination with methotrexate or csDMARD if rescued) after implementation of Protocol Amendment 6 (December 2019) up to Week 260.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/314 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
20/317 • Number of events 31 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
16/314 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.6%
22/335 • Number of events 34 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
18/332 • Number of events 24 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
4/181 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
7/218 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.3%
4/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.1%
13/314 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
9/317 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
15/314 • Number of events 25 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.3%
11/335 • Number of events 24 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
18/332 • Number of events 39 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
10/181 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.6%
10/218 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/314 • Number of events 15 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.1%
13/317 • Number of events 26 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.0%
25/314 • Number of events 37 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
15/335 • Number of events 32 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.1%
27/332 • Number of events 56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.4%
8/181 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.1%
9/218 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
CATARACT
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/335 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Eye disorders
DRY EYE
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/335 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.1%
13/314 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/317 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
18/314 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.7%
6/56 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.9%
13/335 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.0%
20/332 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/335 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.2%
10/314 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/317 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
16/314 • Number of events 16 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.9%
25/317 • Number of events 33 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.1%
19/314 • Number of events 26 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.1%
27/335 • Number of events 36 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
21/332 • Number of events 28 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.8%
12/314 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.4%
20/314 • Number of events 29 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/317 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.9%
13/335 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
6/332 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/335 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.0%
10/332 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
NAUSEA
|
5.4%
17/314 • Number of events 29 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
18/317 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/314 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.2%
29/314 • Number of events 47 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.9%
25/317 • Number of events 28 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/314 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.5%
25/335 • Number of events 30 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
19/332 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.5%
8/55 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.3%
8/56 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
FATIGUE
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.0%
16/317 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
16/335 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.5%
8/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
15/314 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/317 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
14/314 • Number of events 15 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
21/335 • Number of events 24 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
18/332 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
General disorders
PYREXIA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
9/317 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
12.5%
7/56 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.3%
11/335 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/332 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/335 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.1%
7/332 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
5/181 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.3%
5/218 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
BRONCHITIS
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.6%
24/314 • Number of events 27 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
12.7%
7/55 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.9%
22/317 • Number of events 26 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.6%
27/314 • Number of events 38 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.1%
9/56 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.9%
33/335 • Number of events 37 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.7%
29/332 • Number of events 40 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
5/181 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
7/218 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
COVID-19
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
18/314 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.8%
28/317 • Number of events 28 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
11.0%
37/335 • Number of events 38 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.5%
19/181 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.1%
22/218 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/335 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
CYSTITIS
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/317 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.7%
6/56 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/335 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.3%
11/332 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
5/181 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.3%
5/218 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
GASTROENTERITIS
|
2.2%
7/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.5%
8/55 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/317 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/314 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.1%
9/56 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.9%
13/335 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.0%
10/332 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
HERPES ZOSTER
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
21.8%
12/55 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.1%
32/317 • Number of events 38 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.6%
24/314 • Number of events 26 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
23.2%
13/56 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.1%
34/335 • Number of events 42 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.1%
27/332 • Number of events 29 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.9%
7/181 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.7%
8/218 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
INFLUENZA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.5%
8/55 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
17.9%
10/56 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/335 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.3%
11/332 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
14/314 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/317 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
15/314 • Number of events 15 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.2%
14/335 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
18/332 • Number of events 18 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.1%
13/314 • Number of events 15 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
18/317 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/314 • Number of events 18 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
13.7%
43/314 • Number of events 70 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
40.0%
22/55 • Number of events 49 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
15.1%
48/317 • Number of events 87 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.2%
51/314 • Number of events 72 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
44.6%
25/56 • Number of events 59 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
17.0%
57/335 • Number of events 99 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
17.5%
58/332 • Number of events 79 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.4%
8/181 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.6%
10/218 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/335 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
ORAL HERPES
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
12.7%
7/55 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.0%
16/317 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/314 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.3%
8/56 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
17/335 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.9%
13/332 • Number of events 16 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PERIODONTITIS
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
PHARYNGITIS
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
16/314 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
21.8%
12/55 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/317 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/314 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
23.2%
13/56 • Number of events 24 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.2%
14/335 • Number of events 18 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
18/332 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
4/218 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
SINUSITIS
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/314 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.4%
14/317 • Number of events 27 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
16/335 • Number of events 29 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/332 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
6/335 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.5%
14/314 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
20/317 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
23/314 • Number of events 28 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.9%
31/314 • Number of events 45 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.4%
9/55 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
15.5%
49/317 • Number of events 88 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
13.7%
43/314 • Number of events 72 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.1%
9/56 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
17.6%
59/335 • Number of events 102 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
15.4%
51/332 • Number of events 87 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
5/181 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
7/218 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.4%
20/314 • Number of events 24 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/317 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
18/314 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
13.1%
41/314 • Number of events 59 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
13.6%
43/317 • Number of events 93 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
12.1%
38/314 • Number of events 64 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
15.2%
51/335 • Number of events 107 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
13.6%
45/332 • Number of events 76 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.2%
13/181 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.7%
19/218 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.5%
8/55 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/317 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
17.9%
10/56 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.3%
11/335 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/332 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.3%
5/218 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/335 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
3.8%
12/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.0%
16/317 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
28/314 • Number of events 34 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.5%
27/317 • Number of events 49 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
28/314 • Number of events 48 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.6%
32/335 • Number of events 58 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.6%
32/332 • Number of events 52 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
4/218 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.5%
8/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/317 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
23/314 • Number of events 27 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.6%
21/317 • Number of events 31 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.6%
24/314 • Number of events 33 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.2%
24/335 • Number of events 35 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.1%
27/332 • Number of events 36 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
9/317 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.8%
34/314 • Number of events 39 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
11.7%
37/317 • Number of events 68 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.2%
51/314 • Number of events 106 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
13.7%
46/335 • Number of events 79 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.3%
54/332 • Number of events 110 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
10/181 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
12/218 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/335 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/332 • Number of events 15 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/335 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/335 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/332 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
WEIGHT INCREASED
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.7%
15/317 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
17/335 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.1%
7/332 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.1%
7/332 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.7%
15/317 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
15/314 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
17/335 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
15/332 • Number of events 18 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/317 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
14/314 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.7%
19/335 • Number of events 27 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
16/332 • Number of events 21 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/335 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/332 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
2.5%
8/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/317 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.6%
21/317 • Number of events 31 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.1%
19/314 • Number of events 31 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/56 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.6%
22/335 • Number of events 33 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
21/332 • Number of events 33 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
4/181 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.3%
5/218 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.1%
13/314 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
20/317 • Number of events 31 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
16/314 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.8%
26/335 • Number of events 40 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
17/332 • Number of events 22 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.8%
6/218 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.9%
6/55 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.3%
20/317 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.4%
20/314 • Number of events 27 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
10.7%
6/56 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.5%
25/335 • Number of events 27 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.9%
23/332 • Number of events 30 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.3%
6/181 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
7/218 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
6/335 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.1%
7/335 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/332 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
6/335 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/332 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/335 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
6.1%
19/314 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.0%
44/314 • Number of events 65 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
29/317 • Number of events 37 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
11.6%
39/335 • Number of events 57 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
12/332 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.4%
17/181 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
11.5%
25/218 • Number of events 31 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
DIZZINESS
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/317 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/314 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/335 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/332 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
HEADACHE
|
1.9%
6/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.2%
7/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
14/314 • Number of events 16 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
17/314 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/317 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.7%
21/314 • Number of events 26 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.1%
4/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
18/335 • Number of events 20 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.4%
28/332 • Number of events 33 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
4/218 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Nervous system disorders
POST HERPETIC NEURALGIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Psychiatric disorders
INSOMNIA
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.0%
16/317 • Number of events 18 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.1%
17/335 • Number of events 19 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/332 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/332 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/335 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/317 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.2%
10/314 • Number of events 11 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.8%
15/314 • Number of events 15 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
7.6%
24/317 • Number of events 28 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.1%
19/314 • Number of events 23 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/56 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.7%
29/335 • Number of events 35 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
6.6%
22/332 • Number of events 26 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/317 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.63%
2/317 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.90%
3/332 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/317 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.2%
4/335 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.60%
2/332 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/314 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/335 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.30%
1/332 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/181 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/218 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.32%
1/314 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.32%
1/317 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.96%
3/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/314 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.4%
8/335 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
6/332 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.7%
3/181 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.4%
3/218 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.96%
3/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.00%
0/55 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.95%
3/317 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.64%
2/314 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.9%
6/317 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/314 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.4%
3/56 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
6/335 • Number of events 7 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.5%
5/332 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.55%
1/181 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.46%
1/218 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.6%
5/314 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.6%
5/317 • Number of events 6 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.3%
4/314 • Number of events 4 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.9%
9/314 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.1%
5/55 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.5%
8/317 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.5%
11/314 • Number of events 13 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
8.9%
5/56 • Number of events 5 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
2.7%
9/335 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.9%
13/332 • Number of events 17 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
1.1%
2/181 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
0.92%
2/218 • Number of events 2 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
|
Vascular disorders
HYPERTENSION
|
2.5%
8/314 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
3.8%
12/317 • Number of events 12 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.5%
14/314 • Number of events 14 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
9.9%
31/314 • Number of events 34 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.5%
8/55 • Number of events 9 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
11.4%
36/317 • Number of events 40 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.0%
44/314 • Number of events 46 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
16.1%
9/56 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
12.8%
43/335 • Number of events 48 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
14.2%
47/332 • Number of events 51 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.4%
8/181 • Number of events 8 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
4.6%
10/218 • Number of events 10 • From first dose of study drug up to 30 days after last dose, maximum of 264 weeks; Adverse events (AEs) are reported for Weeks 1 to 24, Weeks 1 to 260, and After Switch for participants who transitioned from upadacitinib 30 mg QD to 15 mg QD after implementation of Protocol Amendment 6 in December 2019.
In Weeks 1 to 24 all participants received monotherapy. For Weeks 1 to 260 and After Switch, AEs are reported for the following: * Monotherapy: includes participants receiving monotherapy until the end of study or until rescue treatment was initiated. * All upadacitinib: includes any exposure to upadacitinib, alone or in addition to methotrexate or csDMARD after rescue, including participants originally assigned to methotrexate who were rescued with methotrexate + upadacitinib at Week 26.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER