Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis (NCT NCT03682705)
NCT ID: NCT03682705
Last Updated: 2021-05-03
Results Overview
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
242 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2021-05-03
Participant Flow
Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug
Participant milestones
| Measure |
ELS Placebo/UPA Placebo
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
62
|
41
|
39
|
41
|
40
|
|
Overall Study
COMPLETED
|
17
|
58
|
38
|
34
|
35
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
5
|
6
|
2
|
Reasons for withdrawal
| Measure |
ELS Placebo/UPA Placebo
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
4
|
0
|
1
|
|
Overall Study
Other, not specified
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
3
|
0
|
Baseline Characteristics
A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Total
n=242 Participants
Total of all reporting groups
|
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 11.27 • n=8 Participants
|
57.6 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 12.82 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 10.95 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 11.01 • n=21 Participants
|
57.7 years
STANDARD_DEVIATION 10.60 • n=8 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=8 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
220 Participants
n=8 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
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/Ethnicity, Customized
Asian
|
2 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=18 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=54 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=35 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=29 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=34 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=37 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12
|
-1.12 units on a scale
Interval -1.64 to -0.6
|
-2.56 units on a scale
Interval -2.86 to -2.26
|
-1.52 units on a scale
Interval -1.89 to -1.15
|
-1.32 units on a scale
Interval -1.71 to -0.93
|
-1.33 units on a scale
Interval -1.7 to -0.97
|
-2.87 units on a scale
Interval -3.23 to -2.51
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=18 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=57 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=38 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=37 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=37 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI)
Week 12
|
-14.57 units on a scale
Interval -19.77 to -9.36
|
-27.00 units on a scale
Interval -30.05 to -23.95
|
-17.50 units on a scale
Interval -21.22 to -13.78
|
-16.70 units on a scale
Interval -20.62 to -12.78
|
-16.51 units on a scale
Interval -20.27 to -12.75
|
-28.85 units on a scale
Interval -32.48 to -25.21
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI)
Week 2
|
-6.08 units on a scale
Interval -10.48 to -1.67
|
-16.00 units on a scale
Interval -18.53 to -13.47
|
-8.95 units on a scale
Interval -11.99 to -5.91
|
-7.36 units on a scale
Interval -10.44 to -4.27
|
-8.38 units on a scale
Interval -11.48 to -5.28
|
-14.03 units on a scale
Interval -17.04 to -11.02
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI)
Week 4
|
-11.60 units on a scale
Interval -16.38 to -6.82
|
-20.24 units on a scale
Interval -22.97 to -17.5
|
-11.67 units on a scale
Interval -15.01 to -8.34
|
-10.10 units on a scale
Interval -13.5 to -6.7
|
-12.90 units on a scale
Interval -16.22 to -9.58
|
-20.30 units on a scale
Interval -23.57 to -17.03
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI)
Week 8
|
-12.46 units on a scale
Interval -17.52 to -7.4
|
-24.95 units on a scale
Interval -27.86 to -22.05
|
-15.07 units on a scale
Interval -18.65 to -11.49
|
-17.10 units on a scale
Interval -20.83 to -13.38
|
-14.84 units on a scale
Interval -18.42 to -11.26
|
-23.72 units on a scale
Interval -27.2 to -20.24
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86.with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=18 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=57 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=38 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=37 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=37 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
Week 2
|
-6.17 units on a scale
Interval -10.67 to -1.67
|
-17.01 units on a scale
Interval -19.6 to -14.43
|
-8.79 units on a scale
Interval -11.89 to -5.68
|
-7.42 units on a scale
Interval -10.57 to -4.26
|
-8.54 units on a scale
Interval -11.71 to -5.38
|
-15.30 units on a scale
Interval -18.37 to -12.22
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
Week 4
|
-11.80 units on a scale
Interval -16.67 to -6.93
|
-21.24 units on a scale
Interval -24.02 to -18.45
|
-11.46 units on a scale
Interval -14.85 to -8.06
|
-10.15 units on a scale
Interval -13.61 to -6.68
|
-12.87 units on a scale
Interval -16.25 to -9.49
|
-21.59 units on a scale
Interval -24.92 to -18.26
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
Week 8
|
-12.15 units on a scale
Interval -17.35 to -6.95
|
-25.96 units on a scale
Interval -28.95 to -22.98
|
-15.26 units on a scale
Interval -18.94 to -11.57
|
-17.32 units on a scale
Interval -21.17 to -13.46
|
-15.21 units on a scale
Interval -18.89 to -11.53
|
-25.07 units on a scale
Interval -28.65 to -21.49
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
Week 12
|
-14.44 units on a scale
Interval -19.84 to -9.04
|
-28.06 units on a scale
Interval -31.22 to -24.89
|
-18.01 units on a scale
Interval -21.86 to -14.15
|
-17.12 units on a scale
Interval -21.2 to -13.05
|
-16.73 units on a scale
Interval -20.65 to -12.81
|
-29.65 units on a scale
Interval -33.42 to -25.88
|
SECONDARY outcome
Timeframe: At Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12
|
10.5 percentage of participants
Interval 3.55 to 27.35
|
32.3 percentage of participants
Interval 23.41 to 42.59
|
19.5 percentage of participants
Interval 11.36 to 31.44
|
7.7 percentage of participants
Interval 3.12 to 17.76
|
9.8 percentage of participants
Interval 4.46 to 20.04
|
42.5 percentage of participants
Interval 30.52 to 55.43
|
SECONDARY outcome
Timeframe: At Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12
|
21.1 percentage of participants
Interval 9.82 to 39.5
|
41.9 percentage of participants
Interval 32.18 to 52.37
|
22.0 percentage of participants
Interval 13.24 to 34.13
|
10.3 percentage of participants
Interval 4.69 to 20.98
|
14.6 percentage of participants
Interval 7.76 to 25.89
|
55.0 percentage of participants
Interval 42.16 to 67.21
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a CDAI of less than or equal to 10.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 2
|
10.5 percentage of participants
Interval 3.55 to 27.35
|
16.1 percentage of participants
Interval 9.89 to 25.2
|
9.8 percentage of participants
Interval 4.46 to 20.04
|
0 percentage of participants
Interval 0.0 to 6.49
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
12.5 percentage of participants
Interval 6.22 to 23.53
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 4
|
10.5 percentage of participants
Interval 3.55 to 27.35
|
29.0 percentage of participants
Interval 20.59 to 39.23
|
12.2 percentage of participants
Interval 6.06 to 23.01
|
7.7 percentage of participants
Interval 3.12 to 17.76
|
12.2 percentage of participants
Interval 6.06 to 23.01
|
22.5 percentage of participants
Interval 13.59 to 34.9
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 8
|
5.3 percentage of participants
Interval 1.18 to 20.5
|
46.8 percentage of participants
Interval 36.71 to 57.11
|
17.1 percentage of participants
Interval 9.53 to 28.69
|
20.5 percentage of participants
Interval 11.96 to 32.89
|
24.4 percentage of participants
Interval 15.17 to 36.78
|
35.0 percentage of participants
Interval 23.91 to 47.99
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 12
|
26.3 percentage of participants
Interval 13.44 to 45.09
|
37.1 percentage of participants
Interval 27.74 to 47.53
|
34.1 percentage of participants
Interval 23.29 to 46.97
|
17.9 percentage of participants
Interval 10.03 to 30.02
|
17.1 percentage of participants
Interval 9.53 to 28.69
|
57.5 percentage of participants
Interval 44.57 to 69.48
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a CDAI of less than or equal to 2.8.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 8
|
0 percentage of participants
Interval 0.0 to 12.46
|
12.9 percentage of participants
Interval 7.43 to 21.48
|
7.3 percentage of participants
Interval 2.96 to 16.96
|
2.6 percentage of participants
Interval 0.57 to 10.71
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
12.5 percentage of participants
Interval 6.22 to 23.53
|
|
Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 12
|
5.3 percentage of participants
Interval 1.18 to 20.5
|
14.5 percentage of participants
Interval 8.65 to 23.35
|
7.3 percentage of participants
Interval 2.96 to 16.96
|
5.1 percentage of participants
Interval 1.71 to 14.37
|
0 percentage of participants
Interval 0.0 to 6.19
|
15.0 percentage of participants
Interval 7.96 to 26.47
|
|
Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 2
|
0 percentage of participants
Interval 0.0 to 12.46
|
3.2 percentage of participants
Interval 1.07 to 9.29
|
0 percentage of participants
Interval 0.0 to 6.19
|
0 percentage of participants
Interval 0.0 to 6.49
|
0 percentage of participants
Interval 0.0 to 6.19
|
0 percentage of participants
Interval 0.0 to 6.34
|
|
Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Week 4
|
0 percentage of participants
Interval 0.0 to 12.46
|
6.5 percentage of participants
Interval 2.93 to 13.62
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
2.6 percentage of participants
Interval 0.57 to 10.71
|
0 percentage of participants
Interval 0.0 to 6.19
|
2.5 percentage of participants
Interval 0.56 to 10.46
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria: 1. ≥ 20% improvement in 68-tender joint count 2. ≥ 20% improvement in 66-swollen joint count and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 2
|
21.1 percentage of participants
Interval 9.82 to 39.5
|
45.2 percentage of participants
Interval 35.19 to 55.54
|
24.4 percentage of participants
Interval 15.17 to 36.78
|
12.8 percentage of participants
Interval 6.38 to 24.08
|
14.6 percentage of participants
Interval 7.76 to 25.89
|
52.5 percentage of participants
Interval 39.77 to 64.91
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 4
|
42.1 percentage of participants
Interval 25.63 to 60.55
|
51.6 percentage of participants
Interval 41.33 to 61.76
|
29.3 percentage of participants
Interval 19.16 to 41.94
|
23.1 percentage of participants
Interval 13.95 to 35.7
|
22.0 percentage of participants
Interval 13.24 to 34.13
|
55.0 percentage of participants
Interval 42.16 to 67.21
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 8
|
36.8 percentage of participants
Interval 21.37 to 55.59
|
64.5 percentage of participants
Interval 54.11 to 73.71
|
39.0 percentage of participants
Interval 27.55 to 51.86
|
30.8 percentage of participants
Interval 20.2 to 43.84
|
39.0 percentage of participants
Interval 27.55 to 51.86
|
67.5 percentage of participants
Interval 54.55 to 78.23
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 12
|
47.4 percentage of participants
Interval 30.07 to 65.33
|
64.5 percentage of participants
Interval 54.11 to 73.71
|
41.5 percentage of participants
Interval 29.72 to 54.26
|
30.8 percentage of participants
Interval 20.2 to 43.84
|
34.1 percentage of participants
Interval 23.29 to 46.97
|
72.5 percentage of participants
Interval 59.75 to 82.4
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria: 1. ≥ 50% improvement in 68-tender joint count 2. ≥ 50% improvement in 66-swollen joint count and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 2
|
0 percentage of participants
Interval 0.0 to 12.46
|
16.1 percentage of participants
Interval 9.89 to 25.2
|
4.9 percentage of participants
Interval 1.63 to 13.71
|
0 percentage of participants
Interval 0.0 to 6.49
|
0 percentage of participants
Interval 0.0 to 6.19
|
12.5 percentage of participants
Interval 6.22 to 23.53
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 8
|
5.3 percentage of participants
Interval 1.18 to 20.5
|
41.9 percentage of participants
Interval 32.18 to 52.37
|
19.5 percentage of participants
Interval 11.36 to 31.44
|
12.8 percentage of participants
Interval 6.38 to 24.08
|
7.3 percentage of participants
Interval 2.96 to 16.96
|
40.0 percentage of participants
Interval 28.29 to 52.98
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 12
|
21.1 percentage of participants
Interval 9.82 to 39.5
|
45.2 percentage of participants
Interval 35.19 to 55.54
|
29.3 percentage of participants
Interval 19.16 to 41.94
|
12.8 percentage of participants
Interval 6.38 to 24.08
|
17.1 percentage of participants
Interval 9.53 to 28.69
|
47.5 percentage of participants
Interval 35.09 to 60.23
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 4
|
10.5 percentage of participants
Interval 3.55 to 27.35
|
19.4 percentage of participants
Interval 12.46 to 28.82
|
17.1 percentage of participants
Interval 9.53 to 28.69
|
2.6 percentage of participants
Interval 0.57 to 10.71
|
4.9 percentage of participants
Interval 1.63 to 13.71
|
30.0 percentage of participants
Interval 19.66 to 42.87
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria: 1. ≥ 70% improvement in 68-tender joint count 2. ≥ 70% improvement in 66-swollen joint count and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 4
|
0 percentage of participants
Interval 0.0 to 12.46
|
9.7 percentage of participants
Interval 5.09 to 17.64
|
4.9 percentage of participants
Interval 1.63 to 13.71
|
2.6 percentage of participants
Interval 0.57 to 10.71
|
0 percentage of participants
Interval 0.0 to 6.19
|
15.0 percentage of participants
Interval 7.96 to 26.47
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 8
|
0 percentage of participants
Interval 0.0 to 12.46
|
17.7 percentage of participants
Interval 11.16 to 27.02
|
4.9 percentage of participants
Interval 1.63 to 13.71
|
2.6 percentage of participants
Interval 0.57 to 10.71
|
0 percentage of participants
Interval 0.0 to 6.19
|
25.0 percentage of participants
Interval 15.57 to 37.6
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 2
|
0 percentage of participants
Interval 0.0 to 12.46
|
8.1 percentage of participants
Interval 3.98 to 15.66
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
0 percentage of participants
Interval 0.0 to 6.49
|
0 percentage of participants
Interval 0.0 to 6.19
|
0 percentage of participants
Interval 0.0 to 6.34
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 12
|
15.8 percentage of participants
Interval 6.49 to 33.62
|
25.8 percentage of participants
Interval 17.81 to 35.82
|
14.6 percentage of participants
Interval 7.76 to 25.89
|
5.1 percentage of participants
Interval 1.71 to 14.37
|
9.8 percentage of participants
Interval 4.46 to 20.04
|
27.5 percentage of participants
Interval 17.6 to 40.25
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=61 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=37 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count 68 (TJC68)
Week 2
|
-2.47 tender joint counts
Interval -6.1 to 1.16
|
-8.42 tender joint counts
Interval -10.53 to -6.31
|
-3.65 tender joint counts
Interval -6.23 to -1.07
|
-3.86 tender joint counts
Interval -6.46 to -1.26
|
-4.88 tender joint counts
Interval -7.43 to -2.33
|
-8.57 tender joint counts
Interval -11.09 to -6.05
|
|
Change From Baseline in Tender Joint Count 68 (TJC68)
Week 4
|
-9.21 tender joint counts
Interval -13.08 to -5.34
|
-11.86 tender joint counts
Interval -14.1 to -9.62
|
-5.16 tender joint counts
Interval -7.93 to -2.39
|
-5.39 tender joint counts
Interval -8.18 to -2.6
|
-8.08 tender joint counts
Interval -10.77 to -5.39
|
-12.76 tender joint counts
Interval -15.46 to -10.06
|
|
Change From Baseline in Tender Joint Count 68 (TJC68)
Week 8
|
-8.82 tender joint counts
Interval -12.85 to -4.79
|
-15.44 tender joint counts
Interval -17.75 to -13.12
|
-8.43 tender joint counts
Interval -11.31 to -5.55
|
-10.83 tender joint counts
Interval -13.78 to -7.88
|
-9.08 tender joint counts
Interval -11.88 to -6.27
|
-14.76 tender joint counts
Interval -17.56 to -11.97
|
|
Change From Baseline in Tender Joint Count 68 (TJC68)
Week 12
|
-8.47 tender joint counts
Interval -12.81 to -4.12
|
-16.33 tender joint counts
Interval -18.84 to -13.83
|
-9.14 tender joint counts
Interval -12.23 to -6.05
|
-9.33 tender joint counts
Interval -12.55 to -6.12
|
-12.58 tender joint counts
Interval -15.64 to -9.52
|
-17.56 tender joint counts
Interval -20.58 to -14.53
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=61 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=37 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count 66 (SJC66)
Week 2
|
-3.12 swollen joint counts
Interval -5.2 to -1.05
|
-6.06 swollen joint counts
Interval -7.26 to -4.86
|
-3.61 swollen joint counts
Interval -5.08 to -2.14
|
-3.30 swollen joint counts
Interval -4.78 to -1.82
|
-4.13 swollen joint counts
Interval -5.6 to -2.67
|
-6.02 swollen joint counts
Interval -7.46 to -4.58
|
|
Change From Baseline in Swollen Joint Count 66 (SJC66)
Week 4
|
-4.70 swollen joint counts
Interval -6.92 to -2.49
|
-7.96 swollen joint counts
Interval -9.24 to -6.68
|
-5.11 swollen joint counts
Interval -6.69 to -3.53
|
-4.67 swollen joint counts
Interval -6.27 to -3.07
|
-6.05 swollen joint counts
Interval -7.6 to -4.51
|
-8.81 swollen joint counts
Interval -10.35 to -7.26
|
|
Change From Baseline in Swollen Joint Count 66 (SJC66)
Week 8
|
-4.32 swollen joint counts
Interval -6.57 to -2.06
|
-10.28 swollen joint counts
Interval -11.57 to -8.99
|
-6.15 swollen joint counts
Interval -7.77 to -4.54
|
-8.08 swollen joint counts
Interval -9.74 to -6.42
|
-7.58 swollen joint counts
Interval -9.15 to -6.0
|
-10.11 swollen joint counts
Interval -11.68 to -8.55
|
|
Change From Baseline in Swollen Joint Count 66 (SJC66)
Week 12
|
-5.58 swollen joint counts
Interval -8.05 to -3.11
|
-10.86 swollen joint counts
Interval -12.29 to -9.44
|
-6.68 swollen joint counts
Interval -8.44 to -4.92
|
-7.85 swollen joint counts
Interval -9.7 to -6.01
|
-8.59 swollen joint counts
Interval -10.35 to -6.83
|
-11.14 swollen joint counts
Interval -12.86 to -9.42
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=59 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=39 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])
Week 12
|
-23.37 units on a scale
Interval -33.74 to -13.01
|
-32.27 units on a scale
Interval -38.32 to -26.23
|
-19.52 units on a scale
Interval -26.97 to -12.06
|
-10.46 units on a scale
Interval -18.38 to -2.55
|
-17.84 units on a scale
Interval -25.13 to -10.55
|
-38.34 units on a scale
Interval -45.57 to -31.12
|
|
Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])
Week 2
|
-14.97 units on a scale
Interval -22.8 to -7.14
|
-24.02 units on a scale
Interval -28.63 to -19.41
|
-10.22 units on a scale
Interval -15.81 to -4.63
|
-8.78 units on a scale
Interval -14.49 to -3.07
|
-7.61 units on a scale
Interval -13.12 to -2.11
|
-15.99 units on a scale
Interval -21.49 to -10.48
|
|
Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])
Week 4
|
-20.87 units on a scale
Interval -29.6 to -12.14
|
-28.17 units on a scale
Interval -33.28 to -23.07
|
-12.95 units on a scale
Interval -19.27 to -6.63
|
-8.41 units on a scale
Interval -14.85 to -1.97
|
-9.91 units on a scale
Interval -15.93 to -3.88
|
-25.58 units on a scale
Interval -31.69 to -19.48
|
|
Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])
Week 8
|
-16.21 units on a scale
Interval -25.97 to -6.45
|
-31.86 units on a scale
Interval -37.5 to -26.22
|
-20.92 units on a scale
Interval -27.96 to -13.88
|
-11.12 units on a scale
Interval -18.46 to -3.79
|
-13.90 units on a scale
Interval -20.64 to -7.16
|
-30.70 units on a scale
Interval -37.47 to -23.92
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=59 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=39 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)
Week 2
|
-11.87 units on a scale
Interval -20.12 to -3.63
|
-23.44 units on a scale
Interval -28.31 to -18.57
|
-11.16 units on a scale
Interval -17.07 to -5.25
|
-6.47 units on a scale
Interval -12.51 to -0.44
|
-5.95 units on a scale
Interval -11.76 to -0.14
|
-14.76 units on a scale
Interval -20.56 to -8.95
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)
Week 4
|
-20.93 units on a scale
Interval -29.91 to -11.94
|
-25.97 units on a scale
Interval -31.24 to -20.7
|
-12.79 units on a scale
Interval -19.32 to -6.26
|
-7.15 units on a scale
Interval -13.79 to -0.5
|
-8.73 units on a scale
Interval -14.94 to -2.51
|
-23.02 units on a scale
Interval -29.31 to -16.73
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)
Week 8
|
-15.14 units on a scale
Interval -25.37 to -4.91
|
-28.05 units on a scale
Interval -33.97 to -22.13
|
-17.25 units on a scale
Interval -24.65 to -9.84
|
-6.27 units on a scale
Interval -14.0 to 1.45
|
-14.25 units on a scale
Interval -21.34 to -7.17
|
-26.79 units on a scale
Interval -33.9 to -19.69
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)
Week 12
|
-19.55 units on a scale
Interval -30.15 to -8.95
|
-30.52 units on a scale
Interval -36.72 to -24.32
|
-19.47 units on a scale
Interval -27.13 to -11.81
|
-8.45 units on a scale
Interval -16.58 to -0.33
|
-16.40 units on a scale
Interval -23.89 to -8.92
|
-33.53 units on a scale
Interval -40.94 to -26.13
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=18 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=58 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=38 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=37 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=38 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Week 4
|
-25.20 units on a scale
Interval -33.52 to -16.89
|
-33.54 units on a scale
Interval -38.26 to -28.82
|
-25.33 units on a scale
Interval -31.11 to -19.55
|
-19.59 units on a scale
Interval -25.49 to -13.69
|
-18.31 units on a scale
Interval -24.05 to -12.56
|
-34.17 units on a scale
Interval -39.86 to -28.49
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Week 8
|
-24.47 units on a scale
Interval -32.71 to -16.22
|
-40.00 units on a scale
Interval -44.71 to -35.29
|
-30.06 units on a scale
Interval -35.91 to -24.22
|
-33.93 units on a scale
Interval -39.99 to -27.87
|
-25.21 units on a scale
Interval -31.03 to -19.4
|
-41.02 units on a scale
Interval -46.69 to -35.36
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Week 12
|
-23.19 units on a scale
Interval -31.69 to -14.69
|
-46.98 units on a scale
Interval -52.0 to -41.96
|
-30.15 units on a scale
Interval -36.28 to -24.03
|
-31.68 units on a scale
Interval -38.19 to -25.18
|
-24.55 units on a scale
Interval -30.75 to -18.36
|
-50.89 units on a scale
Interval -56.87 to -44.91
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Week 2
|
-16.31 units on a scale
Interval -24.67 to -7.96
|
-22.35 units on a scale
Interval -27.1 to -17.6
|
-19.01 units on a scale
Interval -24.74 to -13.27
|
-16.12 units on a scale
Interval -21.97 to -10.26
|
-11.64 units on a scale
Interval -17.44 to -5.84
|
-24.71 units on a scale
Interval -30.37 to -19.05
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from baseline in the overall score indicates improvement.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=59 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=38 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 2
|
-0.22 units on a scale
Interval -0.37 to -0.06
|
-0.34 units on a scale
Interval -0.43 to -0.25
|
-0.13 units on a scale
Interval -0.24 to -0.02
|
-0.06 units on a scale
Interval -0.17 to 0.05
|
-0.16 units on a scale
Interval -0.27 to -0.05
|
-0.22 units on a scale
Interval -0.33 to -0.11
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 8
|
-0.24 units on a scale
Interval -0.44 to -0.05
|
-0.47 units on a scale
Interval -0.59 to -0.36
|
-0.29 units on a scale
Interval -0.43 to -0.15
|
-0.15 units on a scale
Interval -0.3 to 0.0
|
-0.15 units on a scale
Interval -0.29 to -0.02
|
-0.47 units on a scale
Interval -0.61 to -0.33
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 4
|
-0.36 units on a scale
Interval -0.53 to -0.18
|
-0.39 units on a scale
Interval -0.49 to -0.29
|
-0.11 units on a scale
Interval -0.23 to 0.02
|
-0.14 units on a scale
Interval -0.27 to -0.02
|
-0.21 units on a scale
Interval -0.33 to -0.09
|
-0.33 units on a scale
Interval -0.45 to -0.2
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 12
|
-0.30 units on a scale
Interval -0.52 to -0.08
|
-0.52 units on a scale
Interval -0.65 to -0.39
|
-0.31 units on a scale
Interval -0.46 to -0.15
|
-0.12 units on a scale
Interval -0.28 to 0.05
|
-0.18 units on a scale
Interval -0.33 to -0.03
|
-0.54 units on a scale
Interval -0.7 to -0.39
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline in indicates improvement.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=61 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=37 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)
Week 12
|
1.45 mg/L
Interval -5.1 to 8.0
|
-10.95 mg/L
Interval -14.73 to -7.18
|
-4.58 mg/L
Interval -9.26 to 0.09
|
-5.78 mg/L
Interval -10.77 to -0.78
|
-0.81 mg/L
Interval -5.58 to 3.97
|
-7.44 mg/L
Interval -12.03 to -2.86
|
|
Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)
Week 2
|
-0.51 mg/L
Interval -4.82 to 3.81
|
-9.29 mg/L
Interval -11.79 to -6.8
|
2.26 mg/L
Interval -0.81 to 5.33
|
-0.34 mg/L
Interval -3.43 to 2.74
|
-0.72 mg/L
Interval -3.74 to 2.3
|
-12.27 mg/L
Interval -15.26 to -9.27
|
|
Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)
Week 4
|
1.54 mg/L
Interval -3.72 to 6.79
|
-10.08 mg/L
Interval -13.08 to -7.08
|
2.71 mg/L
Interval -1.05 to 6.46
|
-0.78 mg/L
Interval -4.58 to 3.02
|
0.72 mg/L
Interval -2.91 to 4.35
|
-12.59 mg/L
Interval -16.27 to -8.92
|
|
Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)
Week 8
|
3.23 mg/L
Interval -1.56 to 8.03
|
-9.97 mg/L
Interval -12.7 to -7.24
|
-1.39 mg/L
Interval -4.83 to 2.05
|
-2.58 mg/L
Interval -6.15 to 1.0
|
-2.93 mg/L
Interval -6.26 to 0.39
|
-13.13 mg/L
Interval -16.46 to -9.81
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=59 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=39 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Week 2
|
-0.46 units on a scale
Interval -0.83 to -0.1
|
-1.53 units on a scale
Interval -1.75 to -1.31
|
-0.63 units on a scale
Interval -0.89 to -0.36
|
-0.44 units on a scale
Interval -0.71 to -0.18
|
-0.56 units on a scale
Interval -0.82 to -0.3
|
-1.43 units on a scale
Interval -1.69 to -1.17
|
|
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Week 4
|
-0.90 units on a scale
Interval -1.33 to -0.47
|
-1.96 units on a scale
Interval -2.21 to -1.71
|
-0.87 units on a scale
Interval -1.18 to -0.56
|
-0.68 units on a scale
Interval -1.0 to -0.36
|
-0.82 units on a scale
Interval -1.11 to -0.52
|
-1.98 units on a scale
Interval -2.28 to -1.67
|
|
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Week 8
|
-0.78 units on a scale
Interval -1.27 to -0.29
|
-2.40 units on a scale
Interval -2.68 to -2.11
|
-1.21 units on a scale
Interval -1.56 to -0.86
|
-1.24 units on a scale
Interval -1.61 to -0.87
|
-1.11 units on a scale
Interval -1.45 to -0.77
|
-2.34 units on a scale
Interval -2.68 to -2.0
|
|
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Week 12
|
-1.12 units on a scale
Interval -1.64 to -0.6
|
-2.56 units on a scale
Interval -2.86 to -2.26
|
-1.52 units on a scale
Interval -1.89 to -1.15
|
-1.32 units on a scale
Interval -1.71 to -0.93
|
-1.33 units on a scale
Interval -1.7 to -0.97
|
-2.87 units on a scale
Interval -3.23 to -2.51
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
The DAS28-ESR is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 100 mm) are included in the DAS28 -ESR score. Scores on the DAS28-ESR range from 0 to 10; higher scores indicate more disease activity.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=59 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=34 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=39 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)
Week 2
|
-0.46 units on a scale
Interval -0.82 to -0.09
|
-1.48 units on a scale
Interval -1.69 to -1.26
|
-0.52 units on a scale
Interval -0.79 to -0.26
|
-0.46 units on a scale
Interval -0.74 to -0.19
|
-0.57 units on a scale
Interval -0.83 to -0.32
|
-1.32 units on a scale
Interval -1.58 to -1.06
|
|
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)
Week 4
|
-0.86 units on a scale
Interval -1.3 to -0.43
|
-1.93 units on a scale
Interval -2.19 to -1.68
|
-0.79 units on a scale
Interval -1.11 to -0.48
|
-0.59 units on a scale
Interval -0.91 to -0.26
|
-0.92 units on a scale
Interval -1.23 to -0.62
|
-1.90 units on a scale
Interval -2.2 to -1.59
|
|
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)
Week 8
|
-0.80 units on a scale
Interval -1.29 to -0.31
|
-2.41 units on a scale
Interval -2.69 to -2.12
|
-1.07 units on a scale
Interval -1.42 to -0.71
|
-1.15 units on a scale
Interval -1.52 to -0.78
|
-1.20 units on a scale
Interval -1.54 to -0.86
|
-2.31 units on a scale
Interval -2.65 to -1.97
|
|
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)
Week 12
|
-1.18 units on a scale
Interval -1.71 to -0.64
|
-2.53 units on a scale
Interval -2.84 to -2.22
|
-1.41 units on a scale
Interval -1.8 to -1.03
|
-1.24 units on a scale
Interval -1.65 to -0.83
|
-1.44 units on a scale
Interval -1.82 to -1.06
|
-2.88 units on a scale
Interval -3.25 to -2.5
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.
Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=59 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=39 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=35 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=40 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=38 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Stiffness Severity
Week 2
|
-1.76 units on a scale
Interval -2.54 to -0.98
|
-2.02 units on a scale
Interval -2.48 to -1.56
|
-0.91 units on a scale
Interval -1.47 to -0.35
|
-0.68 units on a scale
Interval -1.26 to -0.11
|
-0.59 units on a scale
Interval -1.15 to -0.04
|
-1.84 units on a scale
Interval -2.4 to -1.29
|
|
Change From Baseline in Morning Stiffness Severity
Week 4
|
-1.76 units on a scale
Interval -2.63 to -0.9
|
-2.71 units on a scale
Interval -3.22 to -2.21
|
-0.82 units on a scale
Interval -1.45 to -0.2
|
-0.83 units on a scale
Interval -1.47 to -0.19
|
-1.08 units on a scale
Interval -1.67 to -0.48
|
-2.51 units on a scale
Interval -3.13 to -1.9
|
|
Change From Baseline in Morning Stiffness Severity
Week 12
|
-1.61 units on a scale
Interval -2.6 to -0.63
|
-3.23 units on a scale
Interval -3.81 to -2.65
|
-1.27 units on a scale
Interval -1.99 to -0.56
|
-1.30 units on a scale
Interval -2.06 to -0.55
|
-1.66 units on a scale
Interval -2.36 to -0.97
|
-3.36 units on a scale
Interval -4.06 to -2.67
|
|
Change From Baseline in Morning Stiffness Severity
Week 8
|
-1.67 units on a scale
Interval -2.56 to -0.77
|
-3.07 units on a scale
Interval -3.59 to -2.55
|
-1.30 units on a scale
Interval -1.94 to -0.65
|
-0.97 units on a scale
Interval -1.64 to -0.3
|
-1.50 units on a scale
Interval -2.11 to -0.88
|
-3.07 units on a scale
Interval -3.7 to -2.44
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference (MCID) in HAQ-DI is defined as change from Baseline ≤ -0.22 for rheumatoid arthritis.
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 4
|
68.4 percentage of participants
Interval 49.55 to 82.7
|
54.8 percentage of participants
Interval 44.46 to 64.81
|
34.1 percentage of participants
Interval 23.29 to 46.97
|
41.0 percentage of participants
Interval 29.07 to 54.15
|
53.7 percentage of participants
Interval 41.02 to 65.84
|
45.0 percentage of participants
Interval 32.79 to 57.84
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 2
|
52.6 percentage of participants
Interval 34.67 to 69.93
|
51.6 percentage of participants
Interval 41.33 to 61.76
|
36.6 percentage of participants
Interval 25.4 to 49.43
|
30.8 percentage of participants
Interval 20.2 to 43.84
|
36.6 percentage of participants
Interval 25.4 to 49.43
|
52.5 percentage of participants
Interval 39.77 to 64.91
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 8
|
52.6 percentage of participants
Interval 34.67 to 69.93
|
58.1 percentage of participants
Interval 47.63 to 67.82
|
51.2 percentage of participants
Interval 38.71 to 63.58
|
51.3 percentage of participants
Interval 38.47 to 63.93
|
36.6 percentage of participants
Interval 25.4 to 49.43
|
65.0 percentage of participants
Interval 52.01 to 76.09
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 12
|
47.4 percentage of participants
Interval 30.07 to 65.33
|
58.1 percentage of participants
Interval 47.63 to 67.82
|
53.7 percentage of participants
Interval 41.02 to 65.84
|
43.6 percentage of participants
Interval 31.37 to 56.64
|
43.9 percentage of participants
Interval 31.93 to 56.63
|
55.0 percentage of participants
Interval 42.16 to 67.21
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data
The EULAR Boolean-based definition of remission is as follows: at any time point, a participant must satisfy all of the following: tender joint count ≤1, swollen joint count ≤1, C-reactive protein ≤1 mg/dl and Patient Global Assessment (PGA) ≤1 (on a 0-10 scale).
Outcome measures
| Measure |
ELS Placebo/UPA Placebo
n=19 Participants
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 Participants
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 Participants
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 Participants
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 Participants
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission
Week 2
|
0 percentage of participants
Interval 0.0 to 12.46
|
1.6 percentage of participants
Interval 0.36 to 6.91
|
0 percentage of participants
Interval 0.0 to 6.19
|
0 percentage of participants
Interval 0.0 to 6.49
|
0 percentage of participants
Interval 0.0 to 6.19
|
0 percentage of participants
Interval 0.0 to 6.34
|
|
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission
Week 4
|
0 percentage of participants
Interval 0.0 to 12.46
|
6.5 percentage of participants
Interval 2.93 to 13.62
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
0 percentage of participants
Interval 0.0 to 6.49
|
0 percentage of participants
Interval 0.0 to 6.19
|
2.5 percentage of participants
Interval 0.56 to 10.46
|
|
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission
Week 8
|
0 percentage of participants
Interval 0.0 to 12.46
|
6.5 percentage of participants
Interval 2.93 to 13.62
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
5.1 percentage of participants
Interval 1.71 to 14.37
|
0 percentage of participants
Interval 0.0 to 6.19
|
12.5 percentage of participants
Interval 6.22 to 23.53
|
|
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission
Week 12
|
0 percentage of participants
Interval 0.0 to 12.46
|
11.3 percentage of participants
Interval 6.24 to 19.58
|
9.8 percentage of participants
Interval 4.46 to 20.04
|
2.6 percentage of participants
Interval 0.57 to 10.71
|
2.4 percentage of participants
Interval 0.55 to 10.22
|
10.0 percentage of participants
Interval 4.57 to 20.5
|
Adverse Events
ELS Placebo/UPA Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
UPA 15 mg/ELS 60 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ELS 60 mg/UPA Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
ELS 20 mg/UPA Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
ELS 5 mg/UPA Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
UPA 15 mg/ELS Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ELS Placebo/UPA Placebo
n=19 participants at risk
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 participants at risk
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 participants at risk
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 participants at risk
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 participants at risk
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 participants at risk
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
ELS Placebo/UPA Placebo
n=19 participants at risk
Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS 60 mg
n=62 participants at risk
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
|
ELS 60 mg/UPA Placebo
n=41 participants at risk
60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 20 mg/UPA Placebo
n=39 participants at risk
20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
ELS 5 mg/UPA Placebo
n=41 participants at risk
5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
|
UPA 15 mg/ELS Placebo
n=40 participants at risk
15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
7.3%
3/41 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
PERIPHERAL SWELLING
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
BRONCHITIS
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
SINUSITIS
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
TOOTH INFECTION
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
6.5%
4/62 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
4.9%
2/41 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
7.7%
3/39 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
4.9%
2/41 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
9.8%
4/41 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
4.9%
2/41 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
7.5%
3/40 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
2.4%
1/41 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
BONE DEFORMITY
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
7.3%
3/41 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
7.7%
3/39 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
7.3%
3/41 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL ADENOCARCINOMA
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
4.9%
2/41 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/41 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
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