Trial Outcomes & Findings for A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs (NCT NCT02720523)
NCT ID: NCT02720523
Last Updated: 2023-06-07
Results Overview
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
197 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-06-07
Participant Flow
Participants with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drug (csDMARDs) were enrolled at 49 sites in Japan. The study is currently ongoing, results are reported up to Week 60, as of the data cutoff date of 12 July 2018.
Participants were randomized to 1 of 3 doses of upadacitinib or placebo in Period 1. Participants who completed week 12 could continue in the study; participants in the upadacitinib groups continued on the same dose of upadacitinib, participants in the placebo group switched to upadacitinib 7.5, 15, or 30 mg per the pre-specified randomization.
Participant milestones
| Measure |
Period 1: Placebo
Participants randomized to receive placebo once daily (QD) for 12 weeks in Period 1.
|
Period 1: Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Period 2: Upadacitinib 7.5 mg
Participants received upadacitinib 7.5 mg QD from Week 12 to Week 260 during the long-term extension period.
|
Period 2: Upadacitinib 15 mg
Participants received upadacitinib 15 mg QD from Week 12 to Week 260 during the long-term extension period.
|
Period 2: Upadacitinib 30 mg
Participants received upadacitinib 30 mg QD from Week 12 to Week 260 during the long-term extension period.
|
|---|---|---|---|---|---|---|---|
|
Period 1: Placebo-controlled Period
STARTED
|
49
|
49
|
49
|
50
|
0
|
0
|
0
|
|
Period 1: Placebo-controlled Period
COMPLETED
|
47
|
49
|
47
|
44
|
0
|
0
|
0
|
|
Period 1: Placebo-controlled Period
NOT COMPLETED
|
2
|
0
|
2
|
6
|
0
|
0
|
0
|
|
Period 2: Long-term Extension Period
STARTED
|
0
|
0
|
0
|
0
|
65
|
62
|
60
|
|
Period 2: Long-term Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Long-term Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
65
|
62
|
60
|
Reasons for withdrawal
| Measure |
Period 1: Placebo
Participants randomized to receive placebo once daily (QD) for 12 weeks in Period 1.
|
Period 1: Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Period 2: Upadacitinib 7.5 mg
Participants received upadacitinib 7.5 mg QD from Week 12 to Week 260 during the long-term extension period.
|
Period 2: Upadacitinib 15 mg
Participants received upadacitinib 15 mg QD from Week 12 to Week 260 during the long-term extension period.
|
Period 2: Upadacitinib 30 mg
Participants received upadacitinib 30 mg QD from Week 12 to Week 260 during the long-term extension period.
|
|---|---|---|---|---|---|---|---|
|
Period 1: Placebo-controlled Period
Adverse Event
|
0
|
0
|
1
|
5
|
0
|
0
|
0
|
|
Period 1: Placebo-controlled Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Placebo-controlled Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Placebo-controlled Period
Other
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Period 2: Long-term Extension Period
Ongoing
|
0
|
0
|
0
|
0
|
57
|
54
|
45
|
|
Period 2: Long-term Extension Period
Adverse Event
|
0
|
0
|
0
|
0
|
4
|
7
|
11
|
|
Period 2: Long-term Extension Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Period 2: Long-term Extension Period
Other
|
0
|
0
|
0
|
0
|
2
|
0
|
3
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 13.04 • n=49 Participants
|
55.8 years
STANDARD_DEVIATION 11.02 • n=49 Participants
|
56.0 years
STANDARD_DEVIATION 12.50 • n=49 Participants
|
54.7 years
STANDARD_DEVIATION 12.22 • n=50 Participants
|
55.2 years
STANDARD_DEVIATION 12.14 • n=197 Participants
|
|
Age, Customized
< 40 years
|
7 Participants
n=49 Participants
|
5 Participants
n=49 Participants
|
8 Participants
n=49 Participants
|
3 Participants
n=50 Participants
|
23 Participants
n=197 Participants
|
|
Age, Customized
45 to < 65 years
|
31 Participants
n=49 Participants
|
32 Participants
n=49 Participants
|
30 Participants
n=49 Participants
|
34 Participants
n=50 Participants
|
127 Participants
n=197 Participants
|
|
Age, Customized
≥ 65 years
|
11 Participants
n=49 Participants
|
12 Participants
n=49 Participants
|
11 Participants
n=49 Participants
|
13 Participants
n=50 Participants
|
47 Participants
n=197 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=49 Participants
|
34 Participants
n=49 Participants
|
36 Participants
n=49 Participants
|
43 Participants
n=50 Participants
|
155 Participants
n=197 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=49 Participants
|
15 Participants
n=49 Participants
|
13 Participants
n=49 Participants
|
7 Participants
n=50 Participants
|
42 Participants
n=197 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
49 Participants
n=49 Participants
|
49 Participants
n=49 Participants
|
49 Participants
n=49 Participants
|
50 Participants
n=50 Participants
|
197 Participants
n=197 Participants
|
|
Duration of RA Diagnosis
|
4.8 years
STANDARD_DEVIATION 4.86 • n=49 Participants
|
6.7 years
STANDARD_DEVIATION 7.15 • n=49 Participants
|
5.9 years
STANDARD_DEVIATION 7.20 • n=49 Participants
|
4.5 years
STANDARD_DEVIATION 4.30 • n=50 Participants
|
5.5 years
STANDARD_DEVIATION 6.03 • n=197 Participants
|
|
Prior Biological Disease-modifying Anti-rheumatic Drug (bDMARD) Use
Yes
|
3 Participants
n=49 Participants
|
5 Participants
n=49 Participants
|
6 Participants
n=49 Participants
|
3 Participants
n=50 Participants
|
17 Participants
n=197 Participants
|
|
Prior Biological Disease-modifying Anti-rheumatic Drug (bDMARD) Use
No
|
46 Participants
n=49 Participants
|
44 Participants
n=49 Participants
|
43 Participants
n=49 Participants
|
47 Participants
n=50 Participants
|
180 Participants
n=197 Participants
|
|
Tender Joint Count
|
16.8 joints
STANDARD_DEVIATION 11.42 • n=49 Participants
|
16.3 joints
STANDARD_DEVIATION 8.89 • n=49 Participants
|
17.8 joints
STANDARD_DEVIATION 12.58 • n=49 Participants
|
16.3 joints
STANDARD_DEVIATION 10.79 • n=50 Participants
|
16.8 joints
STANDARD_DEVIATION 10.93 • n=197 Participants
|
|
Swollen Joint Count
|
10.9 joints
STANDARD_DEVIATION 4.65 • n=49 Participants
|
11.7 joints
STANDARD_DEVIATION 4.89 • n=49 Participants
|
14.0 joints
STANDARD_DEVIATION 7.82 • n=49 Participants
|
11.7 joints
STANDARD_DEVIATION 5.32 • n=50 Participants
|
12.1 joints
STANDARD_DEVIATION 5.88 • n=197 Participants
|
|
Patient's Assessment of Pain
|
56.1 mm
STANDARD_DEVIATION 20.83 • n=49 Participants
|
57.8 mm
STANDARD_DEVIATION 22.62 • n=49 Participants
|
50.5 mm
STANDARD_DEVIATION 25.41 • n=49 Participants
|
45.5 mm
STANDARD_DEVIATION 21.85 • n=50 Participants
|
52.4 mm
STANDARD_DEVIATION 23.09 • n=197 Participants
|
|
Patient's Global Assessment of Disease Activity
|
53.8 mm
STANDARD_DEVIATION 21.72 • n=49 Participants
|
59.0 mm
STANDARD_DEVIATION 22.51 • n=49 Participants
|
49.3 mm
STANDARD_DEVIATION 24.89 • n=49 Participants
|
47.8 mm
STANDARD_DEVIATION 22.79 • n=50 Participants
|
52.4 mm
STANDARD_DEVIATION 23.25 • n=197 Participants
|
|
Physician's Global Assessment of Disease Activity
|
57.4 mm
STANDARD_DEVIATION 18.62 • n=49 Participants • Participants with available data
|
55.6 mm
STANDARD_DEVIATION 16.65 • n=49 Participants • Participants with available data
|
58.8 mm
STANDARD_DEVIATION 20.21 • n=48 Participants • Participants with available data
|
57.6 mm
STANDARD_DEVIATION 21.38 • n=50 Participants • Participants with available data
|
57.4 mm
STANDARD_DEVIATION 19.19 • n=196 Participants • Participants with available data
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.0 units on a scale
STANDARD_DEVIATION 0.67 • n=49 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 0.67 • n=49 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.67 • n=49 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 0.60 • n=50 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 0.65 • n=197 Participants
|
|
High-sensitivity C-reactive Protein (hsCRP)
|
17.9 mg/L
STANDARD_DEVIATION 20.53 • n=49 Participants
|
13.3 mg/L
STANDARD_DEVIATION 12.80 • n=49 Participants
|
15.8 mg/L
STANDARD_DEVIATION 18.23 • n=49 Participants
|
12.4 mg/L
STANDARD_DEVIATION 13.67 • n=50 Participants
|
14.8 mg/L
STANDARD_DEVIATION 16.62 • n=197 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
|
42.9 percentage of participants
Interval 29.0 to 56.7
|
75.5 percentage of participants
Interval 63.5 to 87.6
|
83.7 percentage of participants
Interval 73.3 to 94.0
|
80.0 percentage of participants
Interval 68.9 to 91.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; multiple imputation was used for missing data.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
|
-0.79 scores on a scale
Interval -1.158 to -0.426
|
-2.08 scores on a scale
Interval -2.43 to -1.727
|
-2.39 scores on a scale
Interval -2.735 to -2.043
|
-2.41 scores on a scale
Interval -2.776 to -2.05
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data at baseline; multiple imputation was used for missing data.
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
|
-0.10 scores on a scale
Interval -0.245 to 0.043
|
-0.41 scores on a scale
Interval -0.545 to -0.267
|
-0.45 scores on a scale
Interval -0.583 to -0.309
|
-0.49 scores on a scale
Interval -0.636 to -0.347
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
|
16.3 percentage of participants
Interval 6.0 to 26.7
|
40.8 percentage of participants
Interval 27.1 to 54.6
|
65.3 percentage of participants
Interval 52.0 to 78.6
|
58.0 percentage of participants
Interval 44.3 to 71.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
|
2.0 percentage of participants
Interval 0.0 to 6.0
|
20.4 percentage of participants
Interval 9.1 to 31.7
|
34.7 percentage of participants
Interval 21.4 to 48.0
|
28.0 percentage of participants
Interval 15.6 to 40.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=48 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=44 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
|
2.88 scores on a scale
Interval 1.03 to 4.72
|
7.21 scores on a scale
Interval 5.43 to 8.99
|
6.38 scores on a scale
Interval 4.6 to 8.15
|
8.81 scores on a scale
Interval 6.93 to 10.68
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.
Low disease activity. was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
|
18.4 percentage of participants
Interval 7.5 to 29.2
|
53.1 percentage of participants
Interval 39.1 to 67.0
|
69.4 percentage of participants
Interval 56.5 to 82.3
|
72.0 percentage of participants
Interval 59.6 to 84.4
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.
Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
|
6.1 percentage of participants
Interval 0.0 to 12.8
|
36.7 percentage of participants
Interval 23.2 to 50.2
|
57.1 percentage of participants
Interval 43.3 to 71.0
|
50.0 percentage of participants
Interval 36.1 to 63.9
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 were considered non-responders.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=49 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=50 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
|
8.2 percentage of participants
Interval 0.5 to 15.8
|
30.6 percentage of participants
Interval 17.7 to 43.5
|
24.5 percentage of participants
Interval 12.4 to 36.5
|
34.0 percentage of participants
Interval 20.9 to 47.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=48 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=44 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12
|
1.81 scores on a scale
Interval -0.35 to 3.97
|
4.47 scores on a scale
Interval 2.38 to 6.55
|
3.60 scores on a scale
Interval 1.53 to 5.68
|
2.66 scores on a scale
Interval 0.48 to 4.85
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants who were working and with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
RA-WIS is a simple validated tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk and no action is needed, scores between 10 and 17 indicate medium risk and appropriate advice and information should be given. If the score is \> 17, it means high risk and it could warrant referral. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=31 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=24 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=18 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12
|
-0.69 scores on a scale
Interval -2.58 to 1.21
|
-3.22 scores on a scale
Interval -5.09 to -1.36
|
-2.74 scores on a scale
Interval -4.75 to -0.74
|
-2.24 scores on a scale
Interval -4.4 to -0.09
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=49 Participants
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 15 mg
n=48 Participants
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
|
Upadacitinib 30 mg
n=44 Participants
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
|---|---|---|---|---|
|
Change From Baseline in the Severity of Morning Stiffness at Week 12
|
-1.02 scores on a scale
Interval -1.65 to -0.39
|
-2.83 scores on a scale
Interval -3.44 to -2.22
|
-2.84 scores on a scale
Interval -3.45 to -2.23
|
-2.98 scores on a scale
Interval -3.62 to -2.34
|
Adverse Events
Period 1: Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Period 1: Upadacitinib 7.5 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Period 1: Upadacitinib 15 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 1: Upadacitinib 30 mg
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 7.5 mg
Serious events: 9 serious events
Other events: 55 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 15 mg
Serious events: 14 serious events
Other events: 55 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 30 mg
Serious events: 18 serious events
Other events: 60 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Period 1: Placebo
n=49 participants at risk
Participants received placebo once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 7.5 mg
n=49 participants at risk
Participants received upadacitinib 7.5 mg once daily for 12 weeks in Period 1
|
Period 1: Upadacitinib 15 mg
n=49 participants at risk
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1
|
Period 1: Upadacitinib 30 mg
n=50 participants at risk
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Period 1+2: Upadacitinib 7.5 mg
n=65 participants at risk
Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 7.5 mg from Week 12 to Week 60.
|
Period 1+2: Upadacitinib 15 mg
n=64 participants at risk
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 15 mg from Week 12 to Week 60.
|
Period 1+2: Upadacitinib 30 mg
n=66 participants at risk
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 30 mg from Week 12 to Week 60.
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.5%
3/66 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.0%
2/66 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Rhinitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Investigations
Philadelphia chromosome positive
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.0%
2/66 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/66 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
Other adverse events
| Measure |
Period 1: Placebo
n=49 participants at risk
Participants received placebo once daily for 12 weeks in Period 1.
|
Period 1: Upadacitinib 7.5 mg
n=49 participants at risk
Participants received upadacitinib 7.5 mg once daily for 12 weeks in Period 1
|
Period 1: Upadacitinib 15 mg
n=49 participants at risk
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1
|
Period 1: Upadacitinib 30 mg
n=50 participants at risk
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
|
Period 1+2: Upadacitinib 7.5 mg
n=65 participants at risk
Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 7.5 mg from Week 12 to Week 60.
|
Period 1+2: Upadacitinib 15 mg
n=64 participants at risk
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 15 mg from Week 12 to Week 60.
|
Period 1+2: Upadacitinib 30 mg
n=66 participants at risk
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 30 mg from Week 12 to Week 60.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.0%
2/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.6%
5/66 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.0%
2/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.1%
6/66 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.7%
5/65 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.0%
2/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.4%
6/64 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
15.2%
10/66 • Number of events 10 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.0%
3/50 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
12.3%
8/65 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.6%
7/66 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
3/49 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
3/49 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
20.0%
13/65 • Number of events 17 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.4%
6/64 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.6%
5/66 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.0%
2/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.7%
3/64 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.6%
5/66 • Number of events 7 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Bronchitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.8%
7/65 • Number of events 7 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Cystitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/65 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.6%
5/66 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.0%
2/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.7%
5/65 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
14.1%
9/64 • Number of events 9 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
15.2%
10/66 • Number of events 10 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Influenza
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
12.3%
8/65 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
14.1%
9/64 • Number of events 10 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.1%
6/66 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
5/49 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.2%
5/49 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
12.2%
6/49 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
18.0%
9/50 • Number of events 11 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
53.8%
35/65 • Number of events 71 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
54.7%
35/64 • Number of events 59 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
43.9%
29/66 • Number of events 64 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Oral herpes
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.7%
5/65 • Number of events 7 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.5%
3/66 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.2%
6/65 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.8%
5/64 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.6%
5/66 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/65 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.6%
7/66 • Number of events 7 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.6%
3/65 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.0%
3/50 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.6%
3/65 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.9%
7/64 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
12.1%
8/66 • Number of events 11 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Investigations
Liver function test increased
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
3/49 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.6%
3/65 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.4%
6/64 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Investigations
Weight increased
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/65 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/64 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/66 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.6%
3/65 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.8%
5/64 • Number of events 5 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.0%
2/66 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Nervous system disorders
Headache
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.0%
3/50 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.6%
3/65 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.7%
3/64 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.1%
6/66 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.5%
1/65 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
9.1%
6/66 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.0%
2/50 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/65 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/49 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/65 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
1.6%
1/64 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.6%
3/65 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
7.8%
5/64 • Number of events 6 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.6%
7/66 • Number of events 10 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.1%
2/49 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
2.0%
1/50 • Number of events 1 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.2%
4/65 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
4.7%
3/64 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
10.6%
7/66 • Number of events 7 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
3/49 • Number of events 3 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/49 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
0.00%
0/50 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
12.3%
8/65 • Number of events 8 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
3.1%
2/64 • Number of events 2 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
6.1%
4/66 • Number of events 4 • Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
|
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