Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) (NCT NCT03978520)
NCT ID: NCT03978520
Last Updated: 2023-07-21
Results Overview
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
COMPLETED
PHASE2
341 participants
Baseline, Week 24
2023-07-21
Participant Flow
Full Analysis Set: all randomized participants who received at least 1 dose of study drug
Participant milestones
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
|
Elsubrutinib 60 mg/Upadacitinib Placebo
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
68
|
62
|
69
|
67
|
|
Overall Study
COMPLETED
|
52
|
52
|
51
|
24
|
29
|
|
Overall Study
NOT COMPLETED
|
23
|
16
|
11
|
45
|
38
|
Reasons for withdrawal
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
|
Elsubrutinib 60 mg/Upadacitinib Placebo
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
3
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
5
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
0
|
1
|
|
Overall Study
COVID-19 infection
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other, not specified
|
9
|
4
|
1
|
1
|
2
|
|
Overall Study
Sponsor decision based on interim analysis data review
|
0
|
0
|
0
|
33
|
24
|
Baseline Characteristics
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)
n=69 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
|
Elsubrutinib 60 mg/Upadacitinib Placebo
n=67 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 11.85 • n=4 Participants
|
42.0 years
STANDARD_DEVIATION 11.84 • n=21 Participants
|
42.1 years
STANDARD_DEVIATION 11.73 • n=8 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
319 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
211 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Race (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
|
0 Participants
n=8 Participants
|
|
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
|
9.1 units on a scale
STANDARD_DEVIATION 3.88 • n=5 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 2.75 • n=7 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 2.75 • n=5 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 2.86 • n=4 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 3.18 • n=21 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 3.12 • n=8 Participants
|
|
Physician's Global Assessment (PhGA) score
|
1.75 units on a scale
STANDARD_DEVIATION 0.440 • n=5 Participants
|
1.80 units on a scale
STANDARD_DEVIATION 0.417 • n=7 Participants
|
1.70 units on a scale
STANDARD_DEVIATION 0.438 • n=5 Participants
|
1.77 units on a scale
STANDARD_DEVIATION 0.422 • n=4 Participants
|
1.77 units on a scale
STANDARD_DEVIATION 0.392 • n=21 Participants
|
1.76 units on a scale
STANDARD_DEVIATION 0.421 • n=8 Participants
|
|
Daily dose of corticosteroid
|
7.937 mg/day
STANDARD_DEVIATION 7.1270 • n=5 Participants
|
6.743 mg/day
STANDARD_DEVIATION 6.3736 • n=7 Participants
|
6.242 mg/day
STANDARD_DEVIATION 6.0920 • n=5 Participants
|
6.891 mg/day
STANDARD_DEVIATION 6.1056 • n=4 Participants
|
6.291 mg/day
STANDARD_DEVIATION 6.1096 • n=21 Participants
|
6.856 mg/day
STANDARD_DEVIATION 6.3885 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
Outcome measures
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
|
37.3 percentage of participants
Interval 26.4 to 48.3
|
48.5 percentage of participants
Interval 36.7 to 60.4
|
54.8 percentage of participants
Interval 42.5 to 67.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
Outcome measures
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24
|
38.7 percentage of participants
Interval 27.6 to 49.7
|
54.4 percentage of participants
Interval 42.6 to 66.2
|
56.5 percentage of participants
Interval 44.1 to 68.8
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \[PhGA\], \< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Outcome measures
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
|
42.7 percentage of participants
Interval 31.5 to 53.9
|
54.4 percentage of participants
Interval 42.6 to 66.2
|
58.1 percentage of participants
Interval 45.8 to 70.3
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).
Outcome measures
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24
|
13.3 percentage of participants
Interval 5.6 to 21.0
|
30.9 percentage of participants
Interval 19.9 to 41.9
|
45.2 percentage of participants
Interval 32.8 to 57.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug with available data; Mixed-Effect Model Repeat Measurement was used. When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
Outcome measures
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=56 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=54 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=48 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
|---|---|---|---|
|
Change From Baseline in Daily Prednisone Dose at Week 24
|
-0.65 mg
Interval -1.57 to 0.28
|
-0.45 mg
Interval -1.38 to 0.48
|
-0.62 mg
Interval -1.6 to 0.36
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug with available data; data as observed. When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Outcome measures
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 Participants
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 Participants
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
|---|---|---|---|
|
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Mild/Moderate
|
2.45 Events per patient-year
Interval 1.92 to 2.99
|
1.39 Events per patient-year
Interval 0.97 to 1.81
|
1.76 Events per patient-year
Interval 1.28 to 2.25
|
|
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Severe
|
0.36 Events per patient-year
Interval 0.16 to 0.56
|
0.26 Events per patient-year
Interval 0.08 to 0.44
|
0.10 Events per patient-year
Interval -0.01 to 0.22
|
|
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Overall
|
2.81 Events per patient-year
Interval 2.24 to 3.38
|
1.65 Events per patient-year
Interval 1.2 to 2.1
|
1.87 Events per patient-year
Interval 1.37 to 2.36
|
Adverse Events
Elsubrutinib Placebo/Upadacitinib Placebo
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
Elsubrutinib Placebo/Upadacitinib 30 mg
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)
Elsubrutinib 60 mg/Upadacitinib Placebo
Serious adverse events
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 participants at risk
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 participants at risk
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 participants at risk
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)
n=69 participants at risk
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
|
Elsubrutinib 60 mg/Upadacitinib Placebo
n=67 participants at risk
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
GASTRITIS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
General disorders
ACCIDENTAL DEATH
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
COVID-19
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
ENDOCARDITIS BACTERIAL
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
MENINGITIS TUBERCULOUS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
MYCOPLASMA INFECTION
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
PELVIC ABSCESS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.2%
2/62 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Investigations
SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY INDEX INCREASED
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LUPUS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
RUPTURED CEREBRAL ANEURYSM
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Renal and urinary disorders
LUPUS NEPHRITIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
2.7%
2/75 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Reproductive system and breast disorders
BREAST MASS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
2.7%
2/75 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Vascular disorders
HYPERTENSIVE URGENCY
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
Other adverse events
| Measure |
Elsubrutinib Placebo/Upadacitinib Placebo
n=75 participants at risk
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
|
ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)
n=68 participants at risk
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
Elsubrutinib Placebo/Upadacitinib 30 mg
n=62 participants at risk
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
|
ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)
n=69 participants at risk
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
|
Elsubrutinib 60 mg/Upadacitinib Placebo
n=67 participants at risk
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
5.3%
4/75 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.8%
4/69 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.0%
6/75 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.4%
3/68 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.5%
4/62 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.3%
3/69 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.0%
2/67 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/75 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/68 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.2%
2/62 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.0%
4/67 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
8.0%
6/75 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.9%
4/68 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.5%
4/62 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
9.0%
6/67 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Gastrointestinal disorders
VOMITING
|
4.0%
3/75 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/68 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.5%
4/62 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.0%
2/67 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
General disorders
FATIGUE
|
2.7%
2/75 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.9%
4/68 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.4%
1/69 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.5%
3/67 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
General disorders
PYREXIA
|
8.0%
6/75 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.4%
3/68 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.8%
3/62 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
BRONCHITIS
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/68 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.5%
4/62 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
COVID-19
|
10.7%
8/75 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.4%
3/68 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
11.3%
7/62 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
11.9%
8/67 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
HERPES ZOSTER
|
4.0%
3/75 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
10.3%
7/68 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.8%
3/62 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.3%
3/69 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.5%
1/67 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.0%
3/75 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
8.8%
6/68 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
7.2%
5/69 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
ORAL HERPES
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
7.4%
5/68 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.8%
3/62 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.3%
3/69 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.7%
8/75 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
10.3%
7/68 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
8.1%
5/62 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
7.2%
5/69 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
7.5%
5/67 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.0%
9/75 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
11.8%
8/68 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
17.7%
11/62 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
7.2%
5/69 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.0%
4/67 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Investigations
WEIGHT INCREASED
|
1.3%
1/75 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.9%
4/68 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.7%
5/75 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.4%
3/68 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
7.5%
5/67 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.3%
4/75 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
4.4%
3/68 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
1.6%
1/62 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/69 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.0%
2/67 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Nervous system disorders
HEADACHE
|
12.0%
9/75 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.9%
4/68 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.2%
2/62 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
10.1%
7/69 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
14.9%
10/67 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
2.7%
2/75 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
2.9%
2/68 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
6.5%
4/62 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/69 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
1.3%
1/75 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.9%
4/68 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
3.2%
2/62 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
5.8%
4/69 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
0.00%
0/67 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
|
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