Trial Outcomes & Findings for A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs (NCT NCT03086343)
NCT ID: NCT03086343
Last Updated: 2024-07-18
Results Overview
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
657 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2024-07-18
Participant Flow
The study had a 24-week, randomized, double-blind, parallel-group, active-controlled period (Period 1) and an open-label long-term extension study (Period 2). Primary Cohort: Participants enrolled under Amendment 4 or 3.01, randomized to upadacitinib 15 mg once daily (QD) or abatacept intravenous (IV)/upadacitinib 15 mg QD.
30 mg Cohort: Participants enrolled under Amendment 3, randomized to upadacitinib 30 mg QD or abatacept IV/upadacitinib 30 mg QD. Starting with Amendment 5, all participants received open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD. One participant who was a screen failure was randomized in error and did not receive study drug (and is not included in any data table).
Participant milestones
| Measure |
Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
|
30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
303
|
309
|
21
|
23
|
|
Period 1
COMPLETED
|
278
|
277
|
18
|
21
|
|
Period 1
NOT COMPLETED
|
25
|
32
|
3
|
2
|
|
Period 2
STARTED
|
277
|
277
|
17
|
20
|
|
Period 2
Entered Period 2 on Study Drug
|
271
|
276
|
17
|
19
|
|
Period 2
Upadacitinib Dose Switch From 30 mg QD to 15 mg QD During Part 2
|
0
|
0
|
12
|
12
|
|
Period 2
No Upadacitinib Dose Switch During Part 2
|
0
|
0
|
5
|
7
|
|
Period 2
COMPLETED
|
207
|
208
|
11
|
12
|
|
Period 2
NOT COMPLETED
|
70
|
69
|
6
|
8
|
Reasons for withdrawal
| Measure |
Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
|
30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
7
|
7
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
6
|
10
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
1
|
3
|
1
|
0
|
|
Period 1
Other, Not Specified
|
10
|
12
|
2
|
1
|
|
Period 1
Missing
|
1
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
20
|
11
|
1
|
2
|
|
Period 2
Withdrawal by Subject
|
15
|
25
|
2
|
2
|
|
Period 2
Lost to Follow-up
|
6
|
11
|
1
|
0
|
|
Period 2
COVID-19 Infection
|
5
|
0
|
0
|
0
|
|
Period 2
COVID-19 Logistical Restrictions
|
1
|
0
|
0
|
0
|
|
Period 2
Other, Not Specified
|
23
|
22
|
2
|
4
|
Baseline Characteristics
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
Baseline characteristics by cohort
| Measure |
Primary Cohort: Upadacitinib 15 mg QD
n=303 Participants
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks.
|
Primary Cohort: Abatacept
n=309 Participants
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20.
|
30 mg Cohort: Upadacitinib 30 mg QD
n=21 Participants
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks.
|
30 mg Cohort: Abatacept
n=23 Participants
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20.
|
Total
n=656 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 40 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Age, Customized
40 - 64 years
|
209 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
443 Participants
n=21 Participants
|
|
Age, Customized
≥ 65 years
|
64 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
145 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
538 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
112 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
238 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
191 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
418 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
288 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
612 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Geographic Region
North America
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Geographic Region
South/Central America
|
98 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
197 Participants
n=21 Participants
|
|
Geographic Region
Western Europe
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Geographic Region
Eastern Europe
|
77 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Geographic Region
Asia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Geographic Region
Other
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Disease Activity Score Based on C-reactive protein (CRP; DAS28 [CRP])
Score > 5.1
|
224 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
499 Participants
n=21 Participants
|
|
Disease Activity Score Based on C-reactive protein (CRP; DAS28 [CRP])
Score ≤ 5.1
|
79 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Disease Activity Score Based on C-reactive protein (CRP; DAS28 [CRP])
Score Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study drug; multiple imputation was used for missing data. (The Statistical Analysis Plan (SAP) excluded the the 30 mg Cohorts from these efficacy analyses.)
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.
Outcome measures
| Measure |
Upadacitinib 15 mg
n=303 Participants
One 15 mg tablet taken once per day by mouth for 24 weeks
|
Abatacept
n=309 Participants
500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
|
|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)
|
-2.52 units on a scale
Interval -2.66 to -2.37
|
-2.00 units on a scale
Interval -2.14 to -1.85
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study drug; multiple imputation was used for missing data. (The Statistical Analysis Plan (SAP) excluded the the 30 mg Cohorts from these efficacy analyses.)
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.
Outcome measures
| Measure |
Upadacitinib 15 mg
n=303 Participants
One 15 mg tablet taken once per day by mouth for 24 weeks
|
Abatacept
n=309 Participants
500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
|
|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
|
-2.52 units on a scale
Interval -2.66 to -2.37
|
-2.00 units on a scale
Interval -2.14 to -1.85
|
SECONDARY outcome
Timeframe: At Week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study drug; participants who prematurely discontinued study drug were considered non-responders after discontinuation. (The Statistical Analysis Plan (SAP) excluded the the 30 mg Cohorts from these efficacy analyses.)
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS 28 score less than 2.6 indicates clinical remission.
Outcome measures
| Measure |
Upadacitinib 15 mg
n=303 Participants
One 15 mg tablet taken once per day by mouth for 24 weeks
|
Abatacept
n=309 Participants
500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
|
30.0 percentage of participants
Interval 24.9 to 35.2
|
13.3 percentage of participants
Interval 9.5 to 17.1
|
Adverse Events
Period 1, Primary and 30 mg Cohorts: Abatacept
Serious events: 7 serious events
Other events: 149 other events
Deaths: 1 deaths
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Serious events: 12 serious events
Other events: 174 other events
Deaths: 2 deaths
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Serious events: 68 serious events
Other events: 221 other events
Deaths: 7 deaths
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Serious events: 64 serious events
Other events: 221 other events
Deaths: 16 deaths
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1, Primary and 30 mg Cohorts: Abatacept
n=332 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20.
|
Period 1, Primary Cohort: Upadacitinib 15 mg QD
n=303 participants at risk
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks.
|
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
n=21 participants at risk
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks.
|
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
n=276 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
n=271 participants at risk
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
n=19 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg QD for 192 weeks.
|
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
n=17 participants at risk
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg QD for 192 weeks.
|
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
n=12 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg QD followed by upadacitinib 15 mg QD for a total of 192 weeks.
|
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
n=12 participants at risk
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg QD followed by upadacitinib 15 mg QD for a total of 192 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Endocrine disorders
GOITRE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
CATARACT
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
DACRYOSTENOSIS ACQUIRED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
GASTRIC DISORDER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
VOLVULUS OF SMALL BOWEL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
CHEST PAIN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
DEATH
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
FAT NECROSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
PAIN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Hepatobiliary disorders
BILIARY OBSTRUCTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
ABSCESS SOFT TISSUE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
BONE ABSCESS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
COVID-19
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/271 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
CELLULITIS STAPHYLOCOCCAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
INFECTIOUS PLEURAL EFFUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
MEDICAL DEVICE SITE ABSCESS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
OPHTHALMIC HERPES ZOSTER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PNEUMONIA
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PYELONEPHRITIS CHRONIC
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
SEPSIS
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
COMMINUTED FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
FOREARM FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
SYNOVIAL RUPTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
CENTRAL OBESITY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE PAIN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
SPINAL STENOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL ADENOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTESTINAL METASTASIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
KAPOSI'S SARCOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA STAGE IV
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MANTLE CELL LYMPHOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SECRETORY ADENOMA OF PITUITARY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN EPITHELIAL CANCER METASTATIC
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
CAUDA EQUINA SYNDROME
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
HEMIPARESIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
MOTOR NEURONE DISEASE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
OCCIPITAL NEURALGIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
SPONDYLITIC MYELOPATHY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
SYNCOPE
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Product Issues
DEVICE BREAKAGE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Product Issues
DEVICE PHYSICAL PROPERTY ISSUE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
ADNEXA UTERI CYST
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
INTERMENSTRUAL BLEEDING
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
MENOMETRORRHAGIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
PELVIC ORGAN PROLAPSE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
VAGINAL PROLAPSE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Surgical and medical procedures
ARTHRODESIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Surgical and medical procedures
WOUND DRAINAGE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Vascular disorders
AORTIC INTRAMURAL HAEMATOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
Other adverse events
| Measure |
Period 1, Primary and 30 mg Cohorts: Abatacept
n=332 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20.
|
Period 1, Primary Cohort: Upadacitinib 15 mg QD
n=303 participants at risk
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks.
|
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
n=21 participants at risk
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks.
|
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
n=276 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
n=271 participants at risk
Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
|
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
n=19 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg QD for 192 weeks.
|
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
n=17 participants at risk
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg QD for 192 weeks.
|
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
n=12 participants at risk
Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg QD followed by upadacitinib 15 mg QD for a total of 192 weeks.
|
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
n=12 participants at risk
Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg QD followed by upadacitinib 15 mg QD for a total of 192 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.4%
15/276 • Number of events 15 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.7%
10/271 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.7%
5/303 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.1%
14/276 • Number of events 26 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Congenital, familial and genetic disorders
TYPE V HYPERLIPIDAEMIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
CATARACT
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
EYE HAEMATOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
4/332 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.2%
4/332 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.9%
13/332 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
8/303 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.1%
14/276 • Number of events 17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DUODENOGASTRIC REFLUX
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.3%
4/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/271 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.0%
11/276 • Number of events 14 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/271 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
8/332 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.6%
11/303 • Number of events 11 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.9%
8/276 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.5%
15/271 • Number of events 16 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
PANCREATIC CYST
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Gastrointestinal disorders
VOMITING
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
CHEST PAIN
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
FATIGUE
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.5%
7/276 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
FEELING HOT
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
PERIPHERAL SWELLING
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
PYREXIA
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
General disorders
SWELLING
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.3%
4/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.0%
11/276 • Number of events 11 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.0%
8/271 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
ASYMPTOMATIC COVID-19
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.5%
7/276 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
BRONCHITIS
|
3.9%
13/332 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
8/303 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.4%
26/276 • Number of events 33 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
16/271 • Number of events 18 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
17.6%
3/17 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
COVID-19
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
17.0%
47/276 • Number of events 53 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
23.6%
64/271 • Number of events 69 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
41.7%
5/12 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
CYSTITIS
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.3%
4/303 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.6%
10/276 • Number of events 16 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.5%
2/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
EAR INFECTION
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.5%
7/276 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
GASTROENTERITIS
|
1.2%
4/332 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.0%
12/303 • Number of events 14 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.3%
12/276 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
HERPES ZOSTER
|
1.2%
4/332 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
12.7%
35/276 • Number of events 35 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.9%
24/271 • Number of events 27 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
INFLUENZA
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.3%
4/303 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.6%
10/276 • Number of events 14 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.4%
12/271 • Number of events 12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.5%
2/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.1%
14/276 • Number of events 14 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/271 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.2%
14/332 • Number of events 15 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
7.3%
22/303 • Number of events 22 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.1%
28/276 • Number of events 39 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
13.7%
37/271 • Number of events 57 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
21.1%
4/19 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
OPHTHALMIC HERPES ZOSTER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PERIODONTITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PHARYNGITIS
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.3%
4/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.9%
8/276 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
PNEUMONIA
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/271 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.5%
2/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
POST PROCEDURAL CELLULITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.6%
10/276 • Number of events 11 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
RHINITIS
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
SCIATICA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.9%
8/276 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/271 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
SINUSITIS
|
1.5%
5/332 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.7%
5/303 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.6%
10/276 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
TOOTH INFECTION
|
0.30%
1/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.5%
15/332 • Number of events 18 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.6%
26/303 • Number of events 31 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.6%
32/276 • Number of events 49 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.1%
30/271 • Number of events 46 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
26.3%
5/19 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
23.5%
4/17 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
16.7%
2/12 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.6%
22/332 • Number of events 28 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
6.6%
20/303 • Number of events 27 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
14.5%
40/276 • Number of events 75 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
14.8%
40/271 • Number of events 67 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
15.8%
3/19 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
BONE CONTUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
CORNEAL ABRASION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
FALL
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.1%
14/276 • Number of events 15 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.4%
12/271 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
SCRATCH
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.6%
14/303 • Number of events 20 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.7%
13/276 • Number of events 24 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.5%
15/271 • Number of events 20 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.0%
12/303 • Number of events 18 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.7%
13/276 • Number of events 22 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
6.3%
17/271 • Number of events 28 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
1.8%
6/332 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.0%
9/303 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.2%
31/276 • Number of events 48 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
16/271 • Number of events 25 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.5%
2/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
ELECTROCARDIOGRAM ABNORMAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
HIGH DENSITY LIPOPROTEIN DECREASED
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
SCAN ADRENAL GLAND ABNORMAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
WEIGHT INCREASED
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.0%
6/303 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.1%
14/276 • Number of events 19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
13/271 • Number of events 18 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Investigations
WHITE BLOOD CELLS URINE POSITIVE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.2%
4/332 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/276 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.9%
8/276 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
13/271 • Number of events 15 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.9%
8/276 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.8%
6/332 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.4%
15/276 • Number of events 15 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.5%
15/271 • Number of events 16 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.0%
10/332 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.0%
6/303 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
7.2%
20/276 • Number of events 25 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
6.6%
18/271 • Number of events 20 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
GREATER TROCHANTERIC PAIN SYNDROME
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.6%
7/271 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.5%
2/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.8%
6/332 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.3%
4/303 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
6.5%
18/276 • Number of events 21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.1%
11/271 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.5%
4/271 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
4.5%
15/332 • Number of events 15 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.6%
11/303 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
14.3%
3/21 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.6%
32/276 • Number of events 57 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.0%
27/271 • Number of events 43 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
SJOGREN'S SYNDROME
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.99%
3/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
9/271 • Number of events 9 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF SPLEEN
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.90%
3/332 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
DIZZINESS
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
HEADACHE
|
3.0%
10/332 • Number of events 11 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.3%
10/303 • Number of events 10 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.3%
12/276 • Number of events 17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.1%
11/271 • Number of events 11 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
PARAESTHESIA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
AFFECT LABILITY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
ANXIETY
|
0.90%
3/332 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/271 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
DEPRESSION
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.2%
6/276 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
3.7%
10/271 • Number of events 14 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/271 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Renal and urinary disorders
BLADDER HYPERTROPHY
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Renal and urinary disorders
RENAL CYST
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.4%
8/332 • Number of events 8 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
2.3%
7/303 • Number of events 7 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.3%
12/276 • Number of events 13 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
6.3%
17/271 • Number of events 20 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.60%
2/332 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/271 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.3%
1/12 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.8%
5/276 • Number of events 5 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.36%
1/276 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
PHOTODERMATOSIS
|
0.00%
0/332 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/276 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/271 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.5%
5/332 • Number of events 6 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.33%
1/303 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
4.8%
1/21 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.72%
2/276 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.74%
2/271 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.9%
1/17 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.66%
2/303 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.5%
2/21 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.4%
4/276 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
10.5%
2/19 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
11.8%
2/17 • Number of events 2 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.30%
1/332 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/303 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
1.1%
3/276 • Number of events 3 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.37%
1/271 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
1/19 • Number of events 1 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/17 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
|
Vascular disorders
HYPERTENSION
|
3.3%
11/332 • Number of events 11 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
5.3%
16/303 • Number of events 16 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/21 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
9.1%
25/276 • Number of events 27 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
8.9%
24/271 • Number of events 26 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/19 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
23.5%
4/17 • Number of events 4 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
0.00%
0/12 • All Cause Mortality: From informed consent through the end of study. Period 1, all arms: median of 168 days. Period 2, Upa 15 mg only arms: median of 1374 days; Upa 30 mg only arms: median of 925 days; Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 450 days; Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD arm: median of 446.5 days.
Adverse Event Time Frame: From informed consent until discontinuation of study drug administration (up to 24 weeks for Period 1 and up to 192 weeks for Period 2), plus 70 days. Per protocol, for analysis of Period 1 safety data, the Primary and 30 mg Cohorts receiving abatacept were combined.
|
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